Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CQ2015A (UDI 00841542101974)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00841542101974), received between Jul 19, 2016 and Dec 12, 2019 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CQ2015A, +19.5 DIOPTER, INTRAOCULAR LENS TORE DURING INJECTION INTO PATIENT'S EYE ON (B)(6) 2019. THE LENS WAS IMPLANTED, REMOVED, AND REPLACED INTRAOPERATIVELY WITH NO PATIENT INJURY. THIS RESOLVED THE PROBLEM. PER THE REPORTER ON 20/NOV/2019, "PATIENT IS HEALING WELL."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9460068 ↗
• MalfunctionSep 19, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A HAPTIC OF A CQ2015A, +19.5 DIOPTER, INTRAOCULAR LENS TORE DUE TO OVERRIDE ON ADVANCEMENT OF INJECTOR. IT WAS REPORTED THAT THERE WAS NO PATIENT CONTACT. BACKUP LENS WAS USED.

  Patient problems: No Patient Involvement

  MAUDE report 7888971 ↗
• MalfunctionMay 3, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT A HAPTIC OF A CQ2015A, +19.5 DIOPTER, INTRAOCULAR LENS TORE. 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 7485203 ↗
• MalfunctionDec 7, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE SURGEON IMPLANTED A CQ2015A, +19.5 DIOPTER, INTRAOCULAR LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. DURING IMPLANATION THE SURGEON NOTICED THE LENS WAS CRACKED. THE LENS WAS REMOVED AND REPLACED WITH A SAME MODEL LENS, DIFFERENT DIOPTER (20.0D). THE REPORTER STATED THAT THERE WAS NO PATIENT INJURY AND THE SURGEON IS VERY SATISFIED WITH THE REPLACEMENT. THE CAUSE OF THE EVENT WAS UNKNOWN, REPORTER WAS NOT SURE IF NOT ENOUGH VISCOELASTIC WAS USED OR IF IT WAS A TECHNICIAN ERROR. THE REPORTER WAS NOT ABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7097253 ↗
• MalfunctionDec 7, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE SURGEON IMPLANTED A CQ2015A, +19.5 DIOPTER, INTRAOCULAR LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. DURING IMPLANTATION, THE SURGEON NOTICED THAT THE LENS WAS CRACKED. THE LENS WAS REMOVED AND THE BACK UP LENS (MFR 2023826-2017-01811) WAS USED BUT IT WAS ALSO NOTED TO BE CRACKED DURING THE IMPLANTAION STAGE. THE BACK UP LENS WAS REMOVED AND REPLACED WITH A SAME MODEL LENS, DIFFERENT DIOPTER (20.0D) .THE REPORTER STATED THAT THERE WAS NO PATIENT INJURY. THE CAUSE OF THE EVENT WAS UNKNOWN, REPORTER WAS NOT SURE IF NOT ENOUGH VISCOELASTIC WAS USED OR IF IT WAS A TECHNICAIN ERROR. REPORTER WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient; Patient Problem/Medical Problem

  MAUDE report 7097192 ↗
• MalfunctionJul 19, 2016Entrapment of Device; Entrapment of Device

  THE REPORTER STATED A CQ2015A COLLAMER THREE PIECE LENS, +19.5 DIOPTER, BECAME STUCK INSIDE AN MTC-60C FP CARTRIDGE. THE REPORTER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5807445 ↗

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