Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204A (UDI 00841542102377)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00841542102377), received between Jul 16, 2016 and Mar 27, 2020 — classified as 4 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A CC4204A, +19.0 DIOPTER, INTRAOCULAR LENS WAS RECEIVED WITH A LENS TEAR ON OPTIC AND HAPTIC. 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 9891492 ↗
• MalfunctionAug 20, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON (B)(6) 2019 A CC4204A, +19.0 DIOPTER, INTRAOCULAR LENS WAS NOTICED TO BE TORN AFTER IMPLANTED INTO THE PATIENT'S RIGHT (OD) EYE. DURING THE INITIAL SURGERY, THE LENS WAS REMOVED AND A BACK-UP LENS WAS IMPLANTED WITH NO PATIENT INJURY. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8910115 ↗
• MalfunctionMay 20, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON NOTICED ON (B)(6) 2019 A CC4204A, +19.0 DIOPTER, INTRAOCULAR LENS TORE DURING INJECTION INTO THE PATIENTS RIGHT EYE (OD). THERE WAS PATIENT CONTACT (LENS TOUCHED THE EYE) WITH NO PATIENT INJURY. THE LENS WAS REMOVED AND BACK UP LENS IMPLANTED WITHIN THE INITIAL SURGERY. CAUSE OF THE EVENT IS REPORTED AS POSSIBLE TECH ERROR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8625108 ↗
• MalfunctionMar 20, 2019Mechanical Jam; Mechanical Jam

  THE REPORTER INDICATED THE SURGEON LOADED A CC4204A COLLAMER SINGLE PIECE LENS, +19.0 DIOPTER, AND WHILE ADVANCING THE PLUNGER TO THE LOADING CHAMBER OF THE CARTRIDGE, THE PLUNGER BENT AND WOULD NOT GO THROUGH INTO THE CARTRIDGE. THERE WAS NO PATIENT CONTACT. THE SURGEON WAS NOT SURE IF THE PLUNGER OR LENS WAS COMPROMISED, SO STOPPED AND USED THE BACKUP LENS, WHICH WAS IMPLANTED WITH NO PROBLEM. THE REPORTER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: No Patient Involvement

  MAUDE report 8438513 ↗
• MalfunctionJan 16, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT, AFTER IMPLANTING A CC4204A INTRAOCULAR LENS, DIOPTER +19.0 INTO THE PATIENT'S EYE, THE SURGEON NOTICED THAT THE LENS WAS TORN. THE REPORTER STATES THAT DURING THE LOADING PROCESS THE TECHNICIAN FELT RESISTANCE IN THE PLUNGER. THIS OCCURRED ON (B)(6) 2018. THE LENS WAS REMOVED INTRAOPERATIVELY AND AN ALTERNATE LENS WAS IMPLANTED ON THE SAME DATE. "NO HARM TO PATIENT" IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8254845 ↗
• MalfunctionJan 16, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT, AFTER LOADING A CC4204A INTRAOCULAR LENS, DIOPTER +19.0 INTO THE INSERTER, THE SURGEON NOTICED THAT A PIECE OF THE LENS WAS MISSING. THE LENS WAS NOT INSERTED. THERE WAS NO PATIENT CONTACT OR HARM. THIS OCCURRED ON (B)(6) 2018. AN ALTERNATE LENS WAS SUCCESSFULLY IMPLANTED ON THE SAME DATE.

  Patient problems: No Patient Involvement

  MAUDE report 8254841 ↗
• InjurySep 25, 2018Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE REPORTER INDICATED THAT, WHILE IMPLANTING A CC4204A INTRAOCULAR LENS, DIOPTER +19.0 INTO THE PATIENT'S LEFT (OS) EYE, THE LENS WAS DAMAGED. THE REPORTER STATES THE "LENS WAS IMPLANTED INTO PATIENT AND RETRIEVED-WAS DAMAGED. MULTIPLE INJECTORS FAILED." "NO INJURY TO PATIENT" IS REPORTED. THIS OCCURRED ON (B)(6) 2018. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7906911 ↗
• MalfunctionFeb 28, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THE SURGEON ATTEMPTED TO INSERT A CC4204A COLLAMER SINGLE PIECE LENS, +19.0 DIOPTER, BUT THE LENS WAS DAMAGED. THERE WAS PATIENT CONTACT BUT NO INJURY. THE BACKUP LENS WAS IMPLANTED. THE REPORTER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7304815 ↗
• InjuryJan 25, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THE SURGEON IMPLANTED A CC4204A COLLAMER SINGLE PIECE LENS, +19.0 DIOPTER, IN THE PATIENT'S EYE ON (B)(6) 2017. THE LENS WAS EXPLANTED AND EXCHANGED ON (B)(6) 2017, FOR A SMALLER DIOPTER LENS. THE SURGEON CUT THE LENS TO REMOVE FROM THE EYE AND THERE WAS NO PATIENT INJURY. THE REPORTER INDICATED THE LENS WAS EXPLANTED DUE TO A MISPOWERED LENS, IT WASN'T THE PATIENTS DESIRED OUTCOME. THE REPORTER INDICATED THE LENS WAS NOT MISLABELED BUT WAS NOT SURE IF IT WAS A POSSIBLE MISCALCULATION.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7219285 ↗
• MalfunctionDec 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A CC4204A, +19.0 DIOPTER, INTRAOCULAR LENS IN THE PATIENT'S EYE (OD) ON (B)(6) 2017. DURING THE INSERTION, THE LENS TORE AND THE INJECTOR BROKE. THERE IS NO PATIENT INJURY AND NO WIDENED INCISION OR SUTURE. THE LENS WAS EXCHANGED WITH A BACK-UP LENS.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7114228 ↗
• MalfunctionNov 15, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT, AS THE SURGEON WAS LOADING A CC4204A INTRAOCULAR LENS, DIOPTER +19.0, IN ORDER TO IMPLANT INTO THE PATIENT'S RIGHT (OD) EYE, THE LENS TORE. REPORTEDLY, THERE WAS NO PATIENT CONTACT WITH THE LENS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7033620 ↗
• MalfunctionNov 7, 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 A CC4204A COLLAMER SINGLE PIECE LENS, +19.0 DIOPTER, WAS DAMAGED AND THERE WAS NO PATIENT CONTACT. THE DOCTOR DECIDED TO USE A THREE PIECE LENS. THE REPORTER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7008163 ↗
• InjuryOct 30, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A CC4204A, +19.0 DIOPTER, INTRAOCULAR LENS IN THE PATIENT'S EYE ON (B)(6) 2017. WHEN THE LENS WAS IMPLANTED, THE DOCTOR NOTICED THAT THE BAG TORE. THE DOCTOR THEN EXCHANGED IT WITH A 3 PIECE LENS. THERE WAS NO PATIENT INJURY.

  Patient problems: Capsular Bag Tear; No Code Available

  MAUDE report 6987328 ↗
• InjuryMay 2, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A CC4204A, +19.0 DIOPTER, COLLAMER SINGLE PIECE INTRAOCULAR LENS WAS RETURNED TO THE MANUFACTURER IN TWO PIECES. RETURNED PRODUCT INDICATED PATIENT CONTACT AND A VITRECTOMY WAS PERFORMED. THE FACILITY INDICATED THERE WAS A CAPSULE TEAR AND THE LENS WAS NOT IMPLANTED. A STAAR PHACO MACHINE WAS NOT USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 6539146 ↗
• MalfunctionFeb 10, 2017No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED DURING SURGERY, THE SURGEON TRIED TO IMPLANT A CC4204A SINGLE-PIECE COLLAMER LENS - +19.0 DIOPTER. THE LENS WOULD NOT ADVANCE OUT OF THE ASICO CARTRIDGE AND EVENTUALLY WAS TORN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6324408 ↗
• MalfunctionJul 16, 2016Torn Material; Torn Material

  THE REPORTER STATED THE SURGEON SAID THE CC4204A COLLAMER SINGLE PIECE LENS +19.0 DIOPTER BECAME CAUGHT ON THE WAY OUT OF THE INJECTOR AND TORE UPON INSERTION. THE LENS WAS CUT TO REMOVE FROM THE EYE. THERE WAS NO PATIENT INJURY AND NO INCISION ENLARGEMENT OR SUTURES. THE BACK UP LENS WAS USED WITH OUT INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5800364 ↗

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