Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CQ2015A (UDI 00841542102001)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00841542102001), received between Aug 5, 2016 and Nov 5, 2019 — classified as 4 injuries, 7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT WHILE INJECTING A CQ2015A INTRAOCULAR LENS, DIOPTER +21.0 INTO THE PATIENT'S RIGHT (OD) EYE, THE LENS TORE. REPORTEDLY, THE LENS WAS IMPLANTED AND REMOVED INTRAOPERATIVELY. THE REPORTER STATES THAT TWO LENSES WERE ATTEMPTED TO BE IMPLANTED INTO THE SAME EYE, THE 3RD WAS IMPLANTED SUCCESSFULLY. THE SCRUB NURSE LOADED THE 1ST TWO LENSES THAT TORE DURING INSERTION. ANOTHER PERSON LOADED THE 3RD LENS WHICH WAS SUCCESSFULLY IMPLANTED. POSSIBLE LOADING ERROR. REFERENCE MFR REPORT# 2023826-2019-02059 FOR ADDITIONAL TORN LENS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9279664 ↗
• MalfunctionNov 5, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT WHILE INJECTING A CQ2015A INTRAOCULAR LENS, DIOPTER +21.0 INTO THE PATIENT'S RIGHT (OD) EYE, THE LENS TORE. REPORTEDLY, THE LENS WAS IMPLANTED AND REMOVED INTRAOPERATIVELY. THE REPORTER STATES THAT TWO LENSES WERE ATTEMPTED TO BE IMPLANTED INTO THE SAME EYE, THE 3RD WAS IMPLANTED SUCCESSFULLY. THE SCRUB NURSE LOADED THE 1ST TWO LENSES THAT TORE DURING INSERTION. ANOTHER PERSON LOADED THE 3RD LENS WHICH WAS SUCCESSFULLY IMPLANTED. POSSIBLE LOADING ERROR. REFERENCE MFR REPORT# 2023826-2019-02058 FOR ADDITIONAL TORN LENS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9279658 ↗
• MalfunctionMay 1, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON (B)(6) 2019 A CQ2015A, +21.0 DIOPTER, INTRAOCULAR LENS "CRACK WAS NOTICED DURING INSERTION". THERE WAS PATIENT CONTACT (LENS TOUCHED THE EYE) WITH NO PATIENT INJURY. THE LENS WAS REMOVED AND A BACK-UP LENS IMPLANTED WITHIN THE SAME SURGERY, ON (B)(6) 2019. CAUSE OF THE EVENT IS REPORTED AS INJECTOR FAILURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8570821 ↗
• MalfunctionJan 22, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A CQ2015A INTRAOCULAR LENS, DIOPTER +21.0 WAS RETURNED WITH NO REASON GIVEN FOR ITS RETURN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8268344 ↗
• InjuryJan 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A CQ2015A INTRAOCULAR LENS, DIOPTER +21.0 WAS "INSERTED AND REMOVED. HAPTIC DID NOT LOOK RIGHT. USED BACK UP LENS. NO PATIENT INJURY." ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Code Available

  MAUDE report 8227430 ↗
• InjuryNov 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT, A CQ2015A INTRAOCULAR LENS, DIOPTER +21.0 WAS "IMPLANTED AND REMOVED." FAIL DATE REPORTED AS (B)(6) 2018. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Code Available

  MAUDE report 8107283 ↗
• InjuryJun 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED AND REMOVED A CQ2015A COLLAMER THREE PIECE LENS, +21.0 DIOPTER. THERE WAS NO PATIENT INJURY. 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

  MAUDE report 7594362 ↗
• MalfunctionMar 7, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT THE SURGEON WAS INSERTING A CQ2015A IMPLANTABLE COLLAMER LENS, +21.0DIOPTER, IN THE PATIENTS RIGHT EYE (OD) AND A HAPTIC TORE OFF. THERE WAS PATIENT CONTACT BUT NO INJURY. THE LENS WAS REMOVED AND THE BACK UP LENS WAS IMPLANTED WITHIN THE SAME SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7322431 ↗
• MalfunctionOct 6, 2017Material Deformation; Material Deformation

  THE REPORTER INDICATED THE SURGEON INSERTED A CQ2015A COLLAMER THREE PIECE LENS, +21.0 DIOPTER, AND THE HAPTIC BENT. THE LENS WAS REMOVED WITH NO PATIENT INJURY. ANOTHER SAME MODEL LENS WAS IMPLANTED. 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 Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6919972 ↗
• InjuryAug 8, 2017Device 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 WAS ATTEMPTING TO IMPLANT A CQ2015A INTRAOCULAR LENS IN THE PATIENT'S LEFT EYE (OS) BUT THE HAPTIC BROKE WHILE BEING INSERTED DUE TO THE LENS BEING LOADED INCORRECTLY. PARS PLANA VITRECTOMY WAS PERFORMED ON THE PATIENT. DURING THE SURGERY, PART OF THE IRIS RIPPED WHEN LENS HAD TO BE REMOVED FROM EYE.

  Patient problems: No Code Available

  MAUDE report 6773528 ↗
• MalfunctionAug 5, 2016Improper or Incorrect Procedure or Method; Torn Material; Improper or Incorrect Procedure or Method; Torn Material

  THE REPORTER STATED THE SURGEON INSERTED THE CQ2015A COLLAMER THREE PIECE LENS +21.0 DIOPTER AND THE LENS WAS NOTED TO BE DAMAGED. THE LENS WAS REMOVED WITH OUT PATIENT INJURY. THE BACK UP LENS WAS USED. THE CAUSE OF THE LENS DAMAGE WAS DUE TO TECHNICIAN ERROR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5850825 ↗

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