Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204A (UDI 00841542102285)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542102285), received between Mar 9, 2017 and Jan 26, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (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.

• MalfunctionJan 26, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON INSERTED A CC4204A COLLAMER SINGLE PIECE LENS, +14.5 DIOPTER, BUT THE LENS SLIPPED OUT OF THE INCISION WHEN THE SURGEON REMOVED THE INJECTOR. ANOTHER SAME MODEL LENS WAS IMPLANTED WITH NO PROBLEMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11231242 ↗
• MalfunctionSep 21, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CC4204A, +14.5 DIOPTER, INTRAOCULAR LENS TORE IN HALF. IT WAS REPORTED THAT THERE WAS NO PATIENT CONTACT. 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 Patient Involvement

  MAUDE report 7897848 ↗
• MalfunctionMar 9, 2017Scratched Material; Scratched Material

  A CC4204A COLLAMER SINGLE PIECE LENS, +14.5 DIOPTER WAS RETURNED TO THE MANUFACTURER DAMAGED. 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 6393943 ↗

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