Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CQ2015A (UDI 00841542102087)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542102087), received between Nov 30, 2016 and Oct 9, 2018 — classified as 1 injury, 2 malfunctions.

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.

• MalfunctionOct 9, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CQ2015A, +25.0 DIOPTER, INTRAOCULAR LENS WAS DAMAGED DURING INSERTION INTO THE EYE. THE LENS WAS IMPLANTED AND REMOVED FROM EYE DURING INITIAL SURGERY ON (B)(6) 2018 WITH NO PATIENT INJURY. BACKUP LENS WAS IMPLANTED AND RESOLVED PROBLEM. REPORTER STATED THAT THE CAUSE OF EVENT WAS DUE TO A TECHNICAL ERROR. THE LENS WAS LOADED WRONG.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7947528 ↗
• InjuryDec 1, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A CQ2015A THREE-PIECE IMPLANTABLE COLLAMER LENS, +25.0 DIOPTER, IN THE PATIENT'S EYE ON (B)(6) 2016. THE LENS WAS EXPLANTED ON (B)(6) 2016 BECAUSE OF A LENS TEAR. THE REPORTER STATED THAT THE LENS DID NOT LOAD CORRECTLY. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 6138939 ↗
• MalfunctionNov 30, 2016No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON IMPLANTED A CQ2015A COLLAMER THREE-PIECE LENS, +25.0 DIOPTER, IN THE PATIENT'S EYE ON (B)(6) 2016. THE LENS WAS INTRAOPERATIVELY REMOVED ON (B)(6) 2016 BECAUSE OF A LENS TEAR. THE REPORTER STATED THAT THE LENS DID NOT LOAD CORRECTLY. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6137144 ↗

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