Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CQ2015A (UDI 00841542101813)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542101813), received between Nov 15, 2017 and Dec 29, 2017 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2017Improper or Incorrect Procedure or Method; Device Operates Differently Than Expected; Improper or Incorrect Procedure or Method; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT AS THE CQ2015A INTRAOCULAR LENS, DIOPTER +17.0 WAS BEING INJECTED INTO THE PATIENT'S EYE, THE LENS "KINKED." REPORTEDLY, THIS WAS DUE TO TECHNICIAN ERROR. THE LENS WAS NOT FULLY IMPLANTED. A BACK-UP LENS WAS IMPLANTED WITHIN THE SAME SURGERY. CLAIMANT STATES THAT A NON-STAAR INJECTOR SYSTEM WAS USED. NO ADDITIONAL INFORMATION AVAILABLE. DATE OF OCCURRENCE IS (B)(6) 2017.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7156014 ↗
• MalfunctionNov 15, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT AS THE SURGEON WAS ATTEMPTING TO LOAD A CQ2015A INTRAOCULAR LENS, DIOPTER +11.5, THE LENS WAS DAMAGED. UPON LENS RETURN, ON THE BOX IT WAS WRITTEN, "OPENED BUT NOT INSERTED. DR. BENT A HAPTIC LOADING IT." ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. DATE OF OCCURRENCE IS (B)(6) 2017.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7033624 ↗

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