Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204A (UDI 00841542102322)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542102322), received between May 24, 2017 and Jul 29, 2020 — classified as 2 injuries, 1 malfunction.

5 other recalls cover devices cleared under the same FDA submission (P990013); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CC4204A, +16.5 DIOPTER, INTRAOCULAR LENS WAS INSERTED INTO THE PATIENTS EYE AND THE DOCTOR FELT IT WAS TOO TIGHT. THE LENS WAS REMOVED AND REPLACED WITH A DIFFERENT LENS, NO PATIENT COMPLICATION NOTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10338047 ↗
• MalfunctionSep 16, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CC4204A, +16.5 DIOPTER, INTRAOCULAR LENS WAS IMPLANTED, REMOVED AND REPLACED DUE TO THE LENS TEARING DURING INJECTION/DELIVERY INTO THE EYE. THERE WAS NO PATIENT INJURY. CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9070932 ↗
• InjuryMay 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER STATED THE SURGEON INSERTED A CC4204A COLLAMER SINGLE PIECE LENS, +16.5 DIOPTER, AND THE SURGEON NOTED A CAPSULE TEAR. THE LENS WAS REMOVED WITHIN THE SAME SURGERY WITH NO PATIENT INJURY, NO ENLARGED INCISION. A VITRECTOMY WAS PERFORMED AND A THREE PIECE LENS WAS IMPLANTED. SUTURES WERE NOT REQUIRED. THE REPORTER STATED THE CAPSULE TEAR MOST LIKELY OCCURRED DURING THE PHACOEMULSIFICATION PROCEDURE (ANOTHER MANUFACTURER) AND WAS NOT PRODUCT RELATED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 6589752 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990013. One submission often covers many models, so check the product and lot details in each record.

• Z-1747-2013 · Jun 10, 2013 · Terminated
  Afinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction.
• Z-1746-2013 · Jun 10, 2013 · Terminated
  nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The IOL is to be implante
• Z-2706-2011 · May 20, 2011 · Terminated
  Brand Name STAAR Surgical Collamer Ultraviolet-Absorbing Posterior Chamber Single Piece Foldable Intraocular Lens Common Names Collamer single piece IOL Collamer plate haptic IOL
• Z-1037-04 · Jun 17, 2004 · Terminated
  STAAR Surgical Intra Occular Lens, Collamer.
• Z-0539-04 · Feb 9, 2004 · Terminated
  Collamer UV One-Piece IntraOcular Lens. Models 4205BF and 4204BF