Advanced Medical Optics, Inc.
United StatesFDA applicant, unverified
- Devices
- 42
- FDA recalls
- 17
At a glance
Market reach
- United States
- FDA recalls
What Advanced Medical Optics, Inc. makes
Advanced Medical Optics, Inc. manufactures ophthalmic surgical systems, including vacuum packs for surgical instruments, vitrectomy cutters and accessories, intraocular lenses (both anterior and posterior chamber), and saline irrigation systems. The company also produces contact lens care solutions such as rewetting drops, lubricant eye drops, multi-purpose solutions, and daily cleaners. Additional products include specialized cartridges for surgical devices and branded contact lens cleaning systems.
The company’s portfolio includes devices regulated as Class I, Class II, and Class III under US regulations, with some products authorised via FDA 510(k) clearances and others through FDA Premarket Approval (PMA). These products are listed in the FDA’s 510(k) and PMA registries. The manufacturer is based in the United States.
Catalogue
Search and filter all 42 devicesFDA recalls
FDA recall records list 17 recalls initiated by Advanced Medical Optics, Inc., the earliest on 2005-06-13 and the most recent on 2008-10-29. By recorded status: 17 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2008
- 29 Oct 2008 Z-0343-2009 Unclassified (pre-2012) Terminated Endotoxin levels above specifications have been noted in some syringes tested for lot number UD30654 of the AMO Healon D Ophthalmic Viscosurgical Device. Endotoxin levels above the maximum USP level may be potential causes of an inflammatory response and/or TASS in patients following surgery.
- 2 Apr 2008 Z-1702-2008 Unclassified (pre-2012) Terminated AMO initiated this field correction event after becoming aware of a trend in complaints associated with AMO Vitrectomy Cutter used in conjunction with the AMO WHITESTAR SIGNATURE Phacoemulsification System. The physician may be unable to make a cut during cataract surgery.
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2007
- 25 May 2007 Z-1092-2007 Unclassified (pre-2012) Terminated In response to information received 05/25/2007 from the U.S. Centers for Disease Control and Prevention (CDC) regarding eye infections from Acanthamoeba, a naturally occurring water-borne organism which can contribute to serious corneal infections. CDC estimates a risk of at least seven times greater for those who use Complete MoisturePlus solution versus those who did not.
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- 25 May 2007 Z-1093-2007 Unclassified (pre-2012) Terminated In response to information received 05/25/2007 from the U.S. Centers for Disease Control and Prevention (CDC) regarding eye infections from Acanthamoeba, a naturally occurring water-borne organism which can contribute to serious corneal infections. CDC estimates a risk of at least seven times greater for those who use Complete MoisturePlus solution versus those who did not.
Full distribution text
- 25 May 2007 Z-1092-2007 Unclassified (pre-2012) Terminated In response to information received 05/25/2007 from the U.S. Centers for Disease Control and Prevention (CDC) regarding eye infections from Acanthamoeba, a naturally occurring water-borne organism which can contribute to serious corneal infections. CDC estimates a risk of at least seven times greater for those who use Complete MoisturePlus solution versus those who did not.
2006
- 29 Nov 2006 Z-0148-2007 Unclassified (pre-2012) Terminated The lenses are incorrectly labeled as 11 diopter lenses; these lenses are actually 22.5 diopters.
- 31 Oct 2006 Z-0267-2007 Unclassified (pre-2012) Terminated These specific serial numbers of lenses are being recalled because AMO has received reports of post-implantation cloudiness related to some lenses contained in this grouping.
- 15 Sep 2006 Z-0344-2007 Unclassified (pre-2012) Terminated Due to a potential sterility issue with the product container. Three lots sold in Japan were found to have bacterial contamination, which compromised sterility.
Because of this production-line issue at the firm's plant in China, AMO is recalling lots that were manufactured on the same production lines during the same production period.
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- 15 Sep 2006 Z-0345-2007 Unclassified (pre-2012) Terminated Due to a potential sterility issue with the product container. Three lots sold in Japan were found to have bacterial contamination, which compromised sterility.
Because of this production-line issue at the firm's plant in China, AMO is recalling lots that were manufactured on the same production lines during the same production period.
Full distribution text
- 15 Sep 2006 Z-0346-2007 Unclassified (pre-2012) Terminated Due to a potential sterility issue with the product container. Three lots sold in Japan were found to have bacterial contamination, which compromised sterility.
Because of this production-line issue at the firm''s plant in China, AMO is recalling lots that were manufactured on the same production lines during the same production period.
Full distribution text
- 15 Sep 2006 Z-0347-2007 Unclassified (pre-2012) Terminated Due to a potential sterility issue with the product container. Three lots sold in Japan were found to have bacterial contamination, which compromised sterility.
Because of this production-line issue at the firm''s plant in China, AMO is recalling lots that were manufactured on the same production lines during the same production period.
Full distribution text
Show all 17 recalls
2006
- 15 Sep 2006 Z-0348-2007 Unclassified (pre-2012) Terminated Due to a potential sterility issue with the product container. Three lots sold in Japan were found to have bacterial contamination, which compromised sterility.
Because of this production-line issue at the firm''s plant in China, AMO is recalling lots that were manufactured on the same production lines during the same production period.
Full distribution text
- 15 Sep 2006 Z-0348-2007 Unclassified (pre-2012) Terminated Due to a potential sterility issue with the product container. Three lots sold in Japan were found to have bacterial contamination, which compromised sterility.
Because of this production-line issue at the firm''s plant in China, AMO is recalling lots that were manufactured on the same production lines during the same production period.
2005
- 5 Oct 2005 Z-0093-06 Unclassified (pre-2012) Terminated A small opening (channel or tunnel) in the seal of the
outer Tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer Tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery.
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- 5 Oct 2005 Z-0094-06 Unclassified (pre-2012) Terminated A small opening (channel or tunnel) in the seal of the
outer Tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer Tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery.
Full distribution text
- 5 Oct 2005 Z-0095-06 Unclassified (pre-2012) Terminated A small opening (channel or tunnel) in the seal of the
outer Tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer Tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery.
Full distribution text
- 5 Oct 2005 Z-0096-06 Unclassified (pre-2012) Terminated A small opening (channel or tunnel) in the seal of the
outer Tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer Tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery.
Full distribution text
- 5 Oct 2005 Z-0097-06 Unclassified (pre-2012) Terminated A small opening (channel or tunnel) in the seal of the
outer Tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer Tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery.
Full distribution text
- 13 Jun 2005 Z-0987-05 Unclassified (pre-2012) Terminated Component mix-up of caps/tips. Absence of red tip indicates improperly that the solution is safe for application to the eye.
- 5 Oct 2005 Z-0093-06 Unclassified (pre-2012) Terminated A small opening (channel or tunnel) in the seal of the
outer Tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer Tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery.
Frequently asked questions
How many devices does Advanced Medical Optics, Inc. have in the registry?
The registry currently lists 42 devices for Advanced Medical Optics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Advanced Medical Optics, Inc.'s devices?
Among its 42 most recently registered devices, Advanced Medical Optics, Inc. has devices listed in FDA 510(k) (8 devices) and FDA PMA (34 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Advanced Medical Optics, Inc.'s devices fall under?
Among its 42 most recently registered devices, the classes recorded for Advanced Medical Optics, Inc.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Advanced Medical Optics, Inc.?
FDA recall records list 17 recalls initiated by Advanced Medical Optics, Inc., the most recent initiated on 29 Oct 2008. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Advanced Medical Optics, Inc. in the registry?
The most recently registered devices listed for Advanced Medical Optics, Inc. include SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK, THE AMO OPHTHALMIC SURGICAL SYSTEM, LENS PLUS REWETTING DROPS and VITRECTOMY CUTTER AND ACCESSORIES.