Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204A (UDI 00841542102506)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542102506), received between Mar 21, 2018 and Dec 3, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

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 3, 2018No Apparent Adverse Event; No Apparent Adverse Event

  A CC4204A INTRAOCULAR LENS, DIOPTER +25.5 WAS RETURNED DAMAGED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8127050 ↗
• InjuryMay 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED AND REMOVED A CC4204A COLLAMER SINGLE PIECE LENS, +25.5 DIOPTER, ON (B)(6) 2018. THE SURGEON DECIDED NOT TO KEEP THE INTRAOCULAR LENS (IOL) IN THE PATIENT, IT APPEARED THERE MIGHT HAVE BEEN LOOSE ZONULES. THE REPORTER INDICATED THERE WAS NO PATIENT INJURY. THE REPORTER INDICATED THE EXPLANT WAS NOT DUE TO IOL. THE LENS WILL NOT BE RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: No Code Available

  MAUDE report 7542802 ↗
• MalfunctionMar 21, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON ATTEMPTED TO LOAD A CC4204A, +25.5 DIOPTER, INTRAOCULAR LENS FOR THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. THE LENS GOT STUCK IN THE CARTRIDGE WHILE PUSHING THE LOADER. THERE WAS NO PATIENT CONTACT WITH THE LENS. A BACK-UP LENS WAS USED AND IT WAS SUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7359035 ↗

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