Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CQ2015A (UDI 00841542101967)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00841542101967), received between Oct 14, 2016 and Jun 22, 2018 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THE SURGEON INSERTED A CQ2015A COLLAMER THREE PIECE LENS, +19.0 DIOPTER, AND THE LENS HAPTIC TORE. THE LENS WAS REMOVED WITHIN THE SAME SURGERY, WITH NO PATIENT INJURY. THE BACKUP LENS WAS IMPLANTED WITH NO PROBLEM. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7631789 ↗
• InjuryMay 2, 2018Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem; Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A CQ2015A, +19.0 DIOPTER, INTRAOCULAR LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. DURING SURGERY, THE SAC OF THE EYE WAS DROPPED. THE SAC WAS DAMAGED DURING PHACO AND THE LENS WOULD NOT CENTER INTO PLACE. THE EYE WAS ALSO DAMAGED WHILE LENS WAS TRYING TO BE INSERTED. THE LENS WAS REMOVED INTRAOPERATIVELY. THERE WAS DAMAGE TO THE EYE, SO AN ANTERIOR VITRECTOMY WAS DONE. AFTERWARDS THE SURGEON INSERTED AN ANTERIOR CHAMBER LENS.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 7481809 ↗
• MalfunctionApr 4, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT WHEN THE SURGEON ATTEMPTED TO IMPLANT A CQ2015A, +19.0 DIOPTER, INTRAOCULAR LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017 THE HAPTIC OF THE LENS WRAPPED AROUND THE INJECTOR. THE LENS WAS DAMAGED AND A BACK-UP LENS WAS IMPLANTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7398185 ↗
• MalfunctionMar 23, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT A CQ2015A INTRAOCULAR LENS, +19.0 DIOPTER, WAS DAMAGED DURING INSERTION. THE LENS WAS REMOVED AND THE BACK UP LENS WAS IMPLANTED WITHIN THE SAME SURGERY WITH NO ISSUES. A STAAR INJECTION SYSTEM WAS USED, UNABLE TO PROVIDE LOT NUMBERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7366363 ↗
• InjuryJan 11, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED CQ2015A, +19.0 DIOPTER, IN THE PATIENT'S EYE ON (B)(6) 2017. THE LENS WAS EXPLANTED DUE TO THE HAPTIC BEING TORE. THERE WAS NO PATIENT INJURY. ATTEMPTS AT OBTAINING ADDITION INFORMATION HAVE BEEN UNSUCCESSFUL.

  Patient problems: No Code Available

  MAUDE report 7183429 ↗
• MalfunctionJun 9, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THE SURGEON INSERTED A CQ2015A COLLAMER THREE PIECE LENS, +19.0DIOPTER, AND THE LENS WAS TORN. THE LENS WAS REMOVED WITHIN THE SAME SURGERY, WITH NO PATIENT INJURY. THE BACKUP LENS WAS IMPLANTED WITH NO PROBLEM. THE REPORTER STATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6632261 ↗
• MalfunctionMar 23, 2017Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  THE REPORTER INDICATED A CQ2015A COLLAMER THREE PIECE LENS, +19.0 DIOPTER, WAS NOT USED DUE TO HAD TROUBLE LOADING THE LENS. THERE WAS NO PATIENT CONTACT. THE REPORTER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6430431 ↗
• MalfunctionOct 14, 2016Torn Material; Torn Material

  THE REPORTER INDICATED THE SURGEON ATTEMPTED TO IMPLANT A CQ2015A, THREE-PIECE COLLAMER LENS, +19.5 DIOPTER ON (B)(6) 2016. THE LENS TORE DURING LOADING. NO PATIENT CONTACT. THE REPORTER DID NOT HAVE ADDITIONAL INFORMATION REGARDING THE LENS.

  Patient problems: Visual Impairment

  MAUDE report 6030222 ↗

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