Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204A (UDI 00841542102490)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542102490), received between Apr 5, 2017 and Dec 28, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (2 reports).

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.

• MalfunctionDec 28, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2017, AFTER REVIEWING A RETURNED LENS, IT WAS DETERMINED THAT A PRODUCT MALFUNCTION MAY HAVE OCCURRED. THE LENS BOX STATES, "NOT USED; TEAR." CLAIMANT STATES TO HAVE NO ADDITIONAL INFORMATION REGARDING THIS LENS. ASSOCIATED LENS IS A CC4204A, DIOPTER +25.0.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7152520 ↗
• MalfunctionJul 19, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED A CC4204A COLLAMER SINGLE PIECE LENS, +25.0 DIOPTER, WAS TORN DURING THE PROCEDURE AND THERE WAS PATIENT CONTACT. THE LENS WAS THROWN AWAY. 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 6726495 ↗
• MalfunctionApr 5, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED A CC4204A COLLAMER SINGLE PIECE LENS, +25.0 DIOPTER, WAS DAMAGED. THE REPORTER WAS UNABLE TO REPORT ANY ADDITIONAL INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6462595 ↗

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