Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CQ2015A (UDI 00841542102025)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00841542102025), received between Dec 6, 2017 and May 20, 2020 — classified as 2 injuries, 5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A CQ2015A COLLAMER THREE PIECE LENS, +22.0 DIOPTER, WAS RECEIVED BY THE MANUFACTURER DAMAGED. THE REPORTER INDICATED THE LENS WAS OPENED AND NOT USED. THERE WAS NO PATIENT CONTACT OR INJURY. THEY DECIDED TO USE A DIFFERENT MODEL LENS PRIOR TO INSERTION. THE REPORTER INDICATED THE CAUSE OF THE LENS DAMAGE WAS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 10075038 ↗
• InjuryJul 26, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON IMPLANTED A CQ2015A COLLAMER THREE PIECE LENS, +22.0 DIOPTER, AND THE HAPTIC WAS NOTED TO BE TORN. THE LENS WAS REMOVED WITH NO PATIENT INJURY, NO INCISION ENLARGEMENT OR SUTURES. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8834093 ↗
• MalfunctionJul 17, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT WHILE PUSHING A CQ2015A, +22.0 DIOPTER, INTRAOCULAR LENS "INTO THE CARTRIDGE INTO BARREL, THE TRAILING HAPTIC WAS NOT ATTACHED" AND THE LENS WAS TAKEN "BACK TO THE TABLE." NO PATIENT CONTACT. PER THE REPORTER A "NEW LENS, CARTRIDGE, AND INJECTOR" WAS USED DURING THE INITIAL SURGERY ON (B)(6) 2019 TO RESOLVE THE PROBLEM. "

  Patient problems: No Patient Involvement

  MAUDE report 8798417 ↗
• InjuryFeb 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED ON (B)(6) 2019 A CQ2015A, +22.0 DIOPTER, INTRAOCULAR LENS WAS "MISS POWERED" AND THE LENS WAS REMOVED. THERE WAS NO PATIENT INJURY. 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 Code Available

  MAUDE report 8355687 ↗
• MalfunctionJul 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  A CQ2015A, +22.0 DIOPTER, INTRAOCULAR LENS WAS RETURNED DAMAGE. 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 7706130 ↗
• MalfunctionApr 17, 2018Improper 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 +22.0 WAS BEING INJECTED INTO THE PATIENT'S EYE, THE TRAILING HAPTIC PORTION OF THE LENS TORE OFF. REPORTEDLY, THIS WAS DUE TO TECHNICIAN ERROR. THE LENS WAS SUCCESSFULLY EXCHANGED INTRAOPERATIVELY WITH AN ALTERNATE LENS. THIS OCCURRED ON (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7438808 ↗
• MalfunctionDec 6, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON ATTEMPTED TO IMPLANT A CQ2015A, +22.0 DIOPTER, INTRAOCULAR LENS IN THE PATIENT'S EYE ON 30 OCT 2017. WHILE LOADING THE LENS, THE HAPTIC BENT. IT WAS NOT IMPLANTED. THE REPORTER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7089428 ↗

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