Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204A (UDI 00841542102292)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841542102292), received between Nov 30, 2017 and Nov 30, 2017 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2017Device Operates Differently Than Expected; Mechanical Jam; Device Operates Differently Than Expected; Mechanical Jam

  THE REPORTER INDICATED THAT, AS THE SURGEON WAS LOADING A CC4204A INTRAOCULAR LENS, DIOPTER +15.0, IN PREPARATION TO IMPLANT INTO THE PATIENT'S LEFT (OS) EYE, THE LENS DID NOT LOAD CORRECTLY. REPORTEDLY, "THE NANOPOINT INJECTOR WAS DEFECTIVE AND DAMAGED THE LENS." SURGEON STATES THERE WAS NO PATIENT CONTACT WITH THE LENS AND A BACK-UP LENS WAS IMPLANTED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7073570 ↗

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-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-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-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