Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204A (UDI 00841542102520)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841542102520), received between May 9, 2018 and Dec 30, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  REPORTEDLY, A CC4204A INTRAOCULAR LENS, DIOPTER +26.5 WAS NOT USED DUE TO THE SURGEON SAW A "DARK SPOT" ON THE LENS. REPORTER STATES THAT A BACK-UP LENS WAS USED INSTEAD. THIS OCCURRED ON (B)(6) 2019. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9532324 ↗
• MalfunctionSep 30, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A CC4204A COLLAMER SINGLE PIECE LENS, +26.5 DIOPTER, RIPPED AND THE LENS WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9136865 ↗
• MalfunctionJul 25, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER STATED THAT A HAPTIC OF A CC4204A INTRAOCULAR LENS, +26.5 DIOPTER, WAS TORN. IT WAS NOTICED BY THE SCRUB TECHNICIAN DURING LOADING. NO PATIENT CONTACT. BACKUP LENS WAS IMPLANTED.

  Patient problems: No Patient Involvement

  MAUDE report 8827109 ↗
• MalfunctionMay 9, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON ATTEMPTED TO IMPLANT A CC4204A, +26.5 DIOPTER, INTRAOCULAR LENS IN THE PATIENT'S EYE ON (B)(6) 2018. IT WAS REPORTED THAT THE LENS TORN WHILE LOADING. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS ABLE TO BE PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7499546 ↗

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