Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CQ2015A (UDI 00841542102018)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00841542102018), received between Nov 11, 2016 and Jan 30, 2020 — classified as 2 injuries, 11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2020No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CQ2015A, +21.50 DIOPTER, INTRAOCULAR LENS TORE UPON LOADING. THERE WAS NO PATIENT CONTACT, BACK UP LENS WAS IMPANTED. CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 9648850 ↗
• MalfunctionJul 16, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A CQ2015A INTRAOCULAR LENS, DIOPTER +21.5 WAS RETURNED DAMAGED 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 8795454 ↗
• MalfunctionApr 25, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT, A CQ2015A INTRAOCULAR LENS, DIOPTER +21.5 WAS DAMAGED DURING INJECTION. THERE WAS NO PATIENT CONTACT WITH THE LENS. REPORTEDLY, THE SURGEON "CLIPPED [THE] HAPTIC WHEN INJECTED BUT DID NOT TOUCH THE PATIENT". THIS OCCURRED ON (B)(6) 2019. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Patient Involvement

  MAUDE report 8552442 ↗
• MalfunctionApr 18, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE HAPTIC OF A CQ2015A COLLAMER THREE PIECE LENS, +21.5 DIOPTER, BROKE. 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 8529662 ↗
• MalfunctionMar 27, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER STATED " LENS WAS LOADED INTO THE CQ CARTRIDGE, LEADING HAPTIC WAS BEND OVER. IT APPEARS THE MSI-TM INJECTOR ROD WAS BENT IN THE UPWARD POSITION. WE DID NOT HAVE THE LOT NUMBER FOR THE INJECTOR AND THE INJECTOR WAS TRASHED. WE GOT ANOTHER INJECTOR, ANOTHER CQ CARTRIDGE AND ANOTHER CQ IOL AND SUCCESSFULLY IMPLANTED INTO THE EYE".

  Patient problems: No Patient Involvement

  MAUDE report 8458401 ↗
• MalfunctionMar 20, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT, WHILE ATTEMPTING TO LOAD A CQ2015A INTRAOCULAR LENS, DIOPTER +21.5, THERE WAS A "LOADING ISSUE." THERE WAS NO PATIENT CONTACT, THE LENS WAS NOT USED. IT IS UNKNOWN WHETHER THIS WAS A MALFUNCTION OF THE PRODUCT OR A LOADING ERROR. THIS OCCURRED ON (B)(6)2019. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Patient Involvement

  MAUDE report 8437902 ↗
• MalfunctionOct 2, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON ATTEMPTED TO INSERT A CQ2015A COLLAMER THREE PIECE LENS, +21.5 DIOPTER, BUT THE LENS SHREDDED GOING THROUGH THE CARTRIDGE. THERE WAS PATIENT CONTACT BUT NO INJURY.

  Patient problems: No Patient Involvement

  MAUDE report 7928323 ↗
• 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 USED.

  Patient problems: No Patient Involvement

  MAUDE report 7888979 ↗
• MalfunctionAug 9, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A HAPTIC OF CQ2015A +21.5 DIOPTER, INTRAOCULAR LENS BENT DURING LOADING. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS USED. CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 7770170 ↗
• InjuryFeb 13, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A CQ2015A, +12.5 DIOPTER, COLLAMER LENS IN THE PATIENT'S EYE ON (B)(6) 2018. AFTER INSERTION THE HAPTIC OF THE LENS TORE WHEN THE SURGEON WHILE TRYING TO SUTURE IN THE LENS. THE LENS WAS EXPLANTED AND THERE WAS NOT ANOTHER LENS THAT WAS IMPLANTED. IT WAS NOTED THAT THE SURGEON DID NOT USE RECOMMENDED CARTRIDGE FOR THE SURGERY.

  Patient problems: No Code Available

  MAUDE report 7268471 ↗
• MalfunctionDec 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A CQ2015A COLLAMER THREE PIECE LENS,+21.5 DIOPTER, WAS IMPLANTED AND REMOVED WITHIN THE SAME SURGERY BECAUSE THE SURGEON NOTICED A PIGMENT ON THE LENS AND THE LENS LOOKED THICKER THAN NORMAL. THE REPORTER STATED THAT THE OR TECHNICIAN INSPECTED THE LENS PRIOR TO LOADING BUT DID NOT NOTICE ANYTHING UNUSUAL WITH THE LENS. THERE WAS NO PATIENT INJURY AND THE BACKUP LENS WAS IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7155973 ↗
• MalfunctionJan 20, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THE SURGEON INSERTED A CQ2015A COLLAMER THREE PIECE LENS, +21.5 DIOPTER, AND THE LENS WAS DAMAGED. THE LENS WAS REMOVED WITHIN THE SAME SURGERY, WITH NO PATIENT INJURY, NO INCISION ENLARGEMENT. THE BACKUP LENS WAS IMPLANTED WITH NO PROBLEM AND PATIENT IS DOING WELL. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS DUE TO TECH/LOADING ERROR, THERE WERE NO ISSUES WITH THE LENS. THE REPORTER INDICATED ANOTHER MANUFACTURERS INJECTION SYSTEM WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6267811 ↗
• InjuryNov 11, 2016Torn Material; Torn Material

  THE REPORTER INDICATED THE SURGEON IMPLANTED A CQ2015A THREE-PIECE COLLAMER LENS, +21.5 DIOPTER, IN THE PATIENT'S EYE ON (B)(6) 2016. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO LENS TEAR CONTRIBUTED TO A FAULTY EPIPHANY INJECTOR. THE REPORTER STATED THAT TWO CASES RESULTED IN ADVERSE EVENTS WITH ENLARGED INCISION AND SUTURE ADDED. REPORTER WAS UNABLE TO PROVIDE DETAILS ON ALL CASES. THE SURGEON IMPLANTED THE BACKUP LENS. NO ADDITIONAL INFORMATION PROVIDED BY REPORTER.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6097776 ↗

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