Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CQ2015A (UDI 00841542101981)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00841542101981), received between Jul 19, 2016 and Aug 24, 2021 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2021Contamination; Contamination

  REPORTEDLY, A CQ2015A INTRAOCULAR LENS, DIOPTER +20.0 WAS RECEIVED WITH A WHITE SPECK ON IT. A BACK-UP LENS WAS IMPLANTED. THERE WAS NO PATIENT CONTACT WITH THE LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12361960 ↗
• MalfunctionOct 3, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A HAPTIC OF CQ2015A, +20.0 DIOPTER, INTRAOCULAR LENS TURNED AROUND THE PLUNGER AND TORE OFF ON INSERTION. THE LENS WAS REMOVED AND ANOTHER LENS WAS IMPLANTED AND PATIENT LEFT IN SATISFACTORY CONDITION. NO PATIENT INJURY OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9152306 ↗
• InjuryJun 26, 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 +20.0 WAS IMPLANTED INTO THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2019 AND REMOVED INTRAOPERATIVELY. DURING EXPLANT, THE LENS WAS DAMAGED. DURING THE SURGICAL PROCEDURE OF IMPLANTING THE IOL, VITREOUS PRESSURE INCREASED POSTERIORLY AND THE CAPSULE RUPTURED. THERE WAS A LOSS OF VITREOUS, A VITRECTOMY WAS PERFORMED, AND INCISION ENLARGED. SUTURES WERE REQUIRED AS PART OF STANDARD PROCEDURE/PROTOCOL. WITHIN THE SAME SURGERY, A 2ND IOL WAS SUCCESSFULLY IMPLANTED.

  Patient problems: Capsular Bag Tear; No Code Available; Vitrectomy; Vitreous Loss

  MAUDE report 8736616 ↗
• MalfunctionApr 25, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT, A CQ2015A INTRAOCULAR LENS, DIOPTER +20.0 WAS TORN DURING LOADING. THERE WAS NO PATIENT CONTACT WITH THE LENS AND A BACK-UP LENS WAS SUCCESSFULLY IMPLANTED. THIS OCCURRED ON (B)(6) 2019. THE CAUSE OF THE EVENT IS REPORTED AS THE SURGEON USING A DIFFERENT VISCOELASTIC TO LOAD THE LENS "WHICH BROKE THE HAPTIC".

  Patient problems: No Patient Involvement

  MAUDE report 8552453 ↗
• MalfunctionSep 13, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A HAPTIC OF A CQ2015A, +20.0 DIOPTER, INTRAOCULAR LENS BROKE. THE LENS WAS IMPLANTED AND REMOVED WITH NO PATIENT INJURY. AN ALCON LENS WAS IMPLANTED WITHIN THE SAME SURGERY. REPORTER WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7874530 ↗
• MalfunctionJun 12, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THERE WAS A LOADING ISSUE WITH A CQ2015A COLLAMER THREE PIECE LENS, +20.0 DIOPTER. THERE WAS PATIENT CONTACT BUT NO INJURY NOTED. THE BACKUP LENS WAS IMPLANTED. THE REPORTER INDICATED THE SURGEON USED A COMPETITOR'S INJECTION SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7594343 ↗
• MalfunctionMay 30, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT A CQ2015A, +20.0 DIOPTER, INTRAOCULAR LENS TORE IN THE INJECTOR. THERE WAS NO PATIENT CONTACT AND THE BACK UP LENS WAS IMPLANTED. THE REPORTER STATED THAT THE CAUSE OF EVENT WAS DUE TO A LOADING ISSUE. A STAAR DELIVERY SYSTEM WAS USED, MODEL AND LOT NUMBERS ARE NOT AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7555268 ↗
• InjuryJan 17, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A CQ2015A INTRAOCULAR LENS, DIOPTER +20.0 INTO THE PATIENT'S EYE ON (B)(6) 2017. REPORTEDLY, ON (B)(6) 2017 THE LENS WAS EXCHANGED WITH A SAME TYPE, DIFFERENT DIOPTER LENS DUE TO THE PATIENT BEING "UNHAPPY WITH VISION." THE PROBLEM WAS RESOLVED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7201665 ↗
• InjurySep 27, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT AS THE SURGEON IMPLANTED A CQ2015A COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULAR LENS, DIOPTER +20.0 INTO THE PATIENT'S EYE, THE LENS TORE/BROKE. REPORTEDLY, WHEN ATTEMPTING TO IMPLANT, THE LEADING HAPTIC AND PART OF THE OPTIC TORE OFF AND STUCK IN THE CARTRIDGE. THE SURGEON NEEDED TO ENLARGE THE INCISION TO REMOVE THE CARTRIDGE. IN ADDITION, IT IS STATED THAT THREE SUTURES WERE USED TO CLOSE THE INCISION. THIS OCCURRED ON (B)(6) 2017. AN ALTERNATE LENS WAS IMPLANTED AND THE PATIENT IS REPORTEDLY IN STABLE CONDITION.

  Patient problems: No Code Available

  MAUDE report 6899555 ↗
• MalfunctionMar 30, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT DURING LOADING A CQ2015A COLLAMER THREE PIECE LENS, +20.0 DIOPTER, IT WAS NOTICED THAT A HAPTIC WAS DAMAGED. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS IMPLANTED. THE REPORTER STATED THAT THE CAUSE OF THE IOL DAMAGE WAS RECEIVED DAMAGE.

  Patient problems: No Patient Involvement

  MAUDE report 6447461 ↗
• MalfunctionMar 11, 2017Mechanical Jam; Mechanical Jam

  A REPORTER INDICATED A CQ2015A COLLAMER THREE PIECE LENS, +20.0 DIOPTER, GOT STUCK IN THE INJECTOR. THE LENS WAS DISCARDED WITH THE 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 6397825 ↗
• MalfunctionJul 19, 2016Torn Material; Torn Material

  THE REPORTER INDICATED THE SURGEON WAS INSERTING A CQ2015A COLLAMER THREE PIECE LENS, +20.0 DIOPTER, AND NOTED THE LENS WAS TEARING. THERE WAS PATIENT CONTACT BUT NO INJURY. ANOTHER SAME MODEL LENS WAS IMPLANTED. THE REPORTER INDICATED THE EVENT WAS DUE TO TECHNICIAN ERROR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5807415 ↗

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