CeeOn Heparin Surface Modified (HSM) UV Light-Absorbing Posterior Chamber IOLs

• • Terminated Z-0096-06 FDA Unclassified (pre-2012) ·initiated 5 Oct 2005 ·on shared PMA P960034

  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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Trade Name

Ceeon Heparin Surface Modified (Asm) Ultraviolet Light.

PMA Number

P960034 ↗

Advisory Committee

Neurology

FDA Decision

APWD Approval withdrawn

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