Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CQ2015A (UDI 00841542101950)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00841542101950), received between May 10, 2017 and Jan 28, 2020 — classified as 1 injury, 14 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2020No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CQ2015A INTRAOCULAR LENS, DIOPTER +18.5 WAS TORN DURING INSERTION. REPORTEDLY, THERE WAS NO PATIENT CONTACT WITH THE LENS. THE CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 9639478 ↗
• MalfunctionOct 22, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT WHILE INJECTING A CQ2015A INTRAOCULAR LENS, DIOPTER +18.5 INTO THE PATIENT'S LEFT (OS) EYE, THE HAPTIC TORE. REPORTEDLY, THERE WAS PATIENT CONTACT WITH THE LENS BUT IT WAS NOT FULLY IMPLANTED. THE CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9221393 ↗
• MalfunctionOct 22, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT PRIOR TO INJECTING A CQ2015A INTRAOCULAR LENS, DIOPTER +18.5, THE HAPTIC WAS NOTED TO BE BENT. REPORTEDLY, THERE WAS NO PATIENT CONTACT WITH THE LENS. THE CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 9221390 ↗
• InjuryOct 22, 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 +18.5 WAS IMPLANTED INTO THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2019. IT WAS NOTED THAT THE HAPTIC WAS BENT. REPORTEDLY, THE LENS WAS REMOVED ON THE SAME DATE BUT NOT INTRAOPERATIVELY. THE CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 9221388 ↗
• MalfunctionOct 22, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT WHILE INJECTING A CQ2015A INTRAOCULAR LENS, DIOPTER +18.5 INTO THE PATIENT'S LEFT (OS) EYE, THE HAPTIC BROKE. REPORTEDLY, THERE WAS PATIENT CONTACT WITH THE LENS BUT IT WAS NOT FULLY IMPLANTED. THE CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9221385 ↗
• MalfunctionFeb 20, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON (B)(6) 2019 A CQ2015A, +18.5 DIOPTER, INTRAOCULAR LENS TORE DURING INJECTION INTO THE EYE. THERE WAS PATIENT CONTACT (LENS TOUCHED THE EYE) WITH NO PATIENT INJURY. THE LENS WAS REMOVED ON (B)(6) 2019. A REPLACEMENT LENS WAS IMPLANTED. PATIENT IS DOING WELL AND HAPPY. IT WAS REPORTED LOADING PROCEDURES REVIEWED WITH SCRUB/TECH. THE CAUSE OF THE EVENT IS RE4PORTED AS "LOADING IOL/INSERTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8354847 ↗
• MalfunctionAug 10, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A HAPTIC OF CQ2015A, +18.5, INTRAOCULAR LENS BROKE DURING LOADING. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS USED. THE CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 7774483 ↗
• MalfunctionMar 28, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A CQ2015A INTRAOCULAR LENS, +18.5 DIOPTER, WAS RETURNED DAMAGE. THE REPORTER STATED THAT THE CAUSE OF THE LENS DAMAGE WAS UNKNOWN. NOT SURE IF IT WAS MISHANDLED OR IF THE WRONG LENS WAS OPENED AND LOADED. REPORTER WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7379951 ↗
• MalfunctionMar 28, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A CQ2015A INTRAOCULAR LENS, +18.5 DIOPTER, WAS RETURNED DAMAGE. THE REPORTER STATED THAT THE CAUSE OF THE LENS DAMAGE WAS UNKNOWN. NOT SURE IF IT WAS MISHANDLED OR IF THE WRONG LENS WAS OPENED AND LOADED. REPORTER WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7379827 ↗
• MalfunctionMar 16, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT A CQ2015A INTRAOCULAR LENS, +18.5 DIOPTER, WAS DAMAGED DURING INSERTION. THE SURGEON HAD TO CUT OUT THE LENS TO REMOVE IT, THERE WAS NO INJURY TO THE PATIENT AND THE BACK UP LENS WAS USED. THE REPORTER STATED THAT AT FIRST THEY THOUGHT IT WAS DUE TO TECHNICIAN ERROR, BUT IT'S HAPPENING TO OFTEN NOW. THE REPORTER STATED THAT WHEN THE SURGEON GOES TO INJECT IT GETS HARD TO PUSH. A STAAR INJECTION SYSTEM WAS USED, UNABLE TO PROVIDE LOT NUMBERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7345006 ↗
• MalfunctionSep 11, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A CQ2015A, +18.5 DIOPTER, INTRAOCULAR LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. DURING IMPLANTATION, THE SURGEON NOTICED THAT TRAILING HAPTIC TORE. THE LENS WAS EXCHANGED WITH A BACK-UP LENS AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6855930 ↗
• MalfunctionAug 3, 2017Device Operates Differently Than Expected; Mechanical Jam; Device Operates Differently Than Expected; Mechanical Jam

  A (B)(4) COLLAMER THREE PIECE LENS, +18.5 DIOPTER, WAS RETURNED STUCK IN THE NOZZLE OF A CARTRIDGE. 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 Known Impact Or Consequence To Patient

  MAUDE report 6765749 ↗
• MalfunctionMay 18, 2017Device Abrasion From Instrument Or Another Object; Device Abrasion From Instrument Or Another Object

  THE REPORTER STATED THAT A CQ2015A, +18.5 DIOPTER, THREE PIECE COLLAMER LENS WAS IMPLANTED AND EXPLANTED DURING THE SAME SURGERY DUE TO A NICK IN THE OPTIC. THE NICK OCCURRED DURING THE LOADING PROCESS DUE TO THE USER NOT USING THE OPTIMAL TYPE OF FORCEPS FOR THIS TYPE OF LENS. THE REPORTER STATED THIS WAS THE FIRST TIME THE USER WAS PERFORMING A PROCEDURE FOR THIS TYPE OF LENS. THERE WAS NO ENLARGEMENT OF THE INCISION AND NO SUTURES NEEDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6576785 ↗
• MalfunctionMay 18, 2017Device Abrasion From Instrument Or Another Object; Device Abrasion From Instrument Or Another Object

  THE REPORTER STATED THAT A CQ2015A, +18.5 DIOPTER, THREE PIECE COLLAMER LENS WAS IMPLANTED AND EXPLANTED DURING THE SAME SURGERY DUE TO A NICK IN THE OPTIC. THE NICK OCCURRED DURING THE LOADING PROCESS DUE TO THE USER NOT USING THE OPTIMAL TYPE OF FORCEPS FOR THIS TYPE OF LENS. THE REPORTER STATED THIS WAS THE FIRST TIME THE USER WAS PERFORMING A PROCEDURE FOR THIS TYPE OF LENS. THERE WAS NO ENLARGEMENT OF THE INCISION AND NO SUTURES NEEDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6575744 ↗
• MalfunctionMay 10, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT A CQ2015A, +18.5 DIOPTER, THREE PIECE COLLAMER LENS WAS DAMAGED DURING LOADING. THE EPIPHANY INJECTOR SYSTEM WAS USED. THE DAMAGE WAS NOT NOTICED UNTIL THE LENS WAS PARTIALLY IMPLANTED IN THE EYE. THE LENS WAS REMOVED WITH NO PATIENT INJURY. THERE WAS NO ENLARGEMENT OR WIDENING OF THE INCISION TO REMOVE THE LENS AND THERE WERE NO SUTURES NEEDED. THE BACK UP LENS WAS LOADED AND INSERTED WITHOUT ANY PROBLEMS. 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

  MAUDE report 6557211 ↗

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