Ophthalmic Fitler Micro Capsule

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K863729 ↗

FDA Product Code

HQC

Device Class

Class II

Regulation

21 CFR Part 886.4670

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

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• What is the primary purpose of the Ophthalmic Filter Micro Capsule during cataract surgery?

  The Ophthalmic Filter Micro Capsule is designed specifically for phacofragmentation procedures in cataract surgery. It acts as a filter to separate and retain microcapsules or emulsified lens fragments, helping surgeons efficiently remove these materials from the eye while minimizing debris in the surgical field.

• Is the Ophthalmic Filter Micro Capsule intended for single-use or reusable applications?

  The device is explicitly supplied as a single-use item, meaning it is intended for one surgical procedure only. This aligns with standard sterile medical device protocols to ensure patient safety and prevent cross-contamination.

• How should the Ophthalmic Filter Micro Capsule be stored to maintain its integrity?

  Since it is a sterile device, storage must follow strict sterile medical device protocols. This includes keeping it in its original packaging, away from moisture, extreme temperatures, and contamination until immediately before use in a controlled surgical environment.

• What regulatory pathway was followed for FDA clearance of the Ophthalmic Filter Micro Capsule?

  The device received FDA clearance through a 510(k) submission, classified as *Traditional* clearance with a *Substantially Equivalent* determination. It falls under Class II regulatory classification and was reviewed by the Ophthalmic (OP) Advisory Committee. The product code HQC categorizes it within ophthalmic surgical instruments.