Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204A (UDI 00841542102391)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00841542102391), received between Feb 19, 2016 and Feb 4, 2021 — classified as 4 injuries, 14 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2021No Apparent Adverse Event; No Apparent Adverse Event

  A CC4204A, +20.00 DIOPTER, INTRAOCULAR LENS WAS RETURNED IN CARTRIDGE. PATIENT CONTACT IS UNKNOWN. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11277280 ↗
• InjuryJan 13, 2021Adverse 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 A CC4204A INTRAOCULAR LENS, DIOPTER +20.0 TORE DURING INSERTION INTO THE PATIENT'S EYE. THIS OCCURRED ON (B)(6) 2020. THE LENS WAS REMOVED AND REPLACED WITH AN ALTERNATE LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11159189 ↗
• MalfunctionSep 27, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CC4204A +20.0 DIOPTER, INTRAOCULAR LENS WAS IMPLANTED AND REMOVED DUE TO A LINEAR CRACK BISECTING THE OPTIC AND ITS ENTIRE DIAMETER IN THE CENTER. THE CRACK WAS NOTICED ONCE THE LENS WAS IN THE EYE. THE LENS WAS REPLACED WITH A BACKUP LENS DURING THE SAME SURGERY. NO PATIENT INJURY WAS REPORTED. CAUSE OF EVENT IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9131877 ↗
• MalfunctionAug 7, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A CC4204A COLLAMER SINGLE PIECE LENS, +20.0 DIOPTER, WAS NOTED TO BE TORN BY THE TECHNICIAN WHILE LOADING AND THERE WAS NO PATIENT CONTACT. A BACKUP LENS WAS IMPLANTED. THE REPORTER WAS UNABLE TO REPORT ANY ADDITIONAL INFORMATION.

  Patient problems: No Patient Involvement

  MAUDE report 8871960 ↗
• MalfunctionMay 15, 2019Mechanical Jam; Device Handling Problem; Mechanical Jam; Device Handling Problem

  THE REPORTER INDICATED THAT A CC4204A, +20.0 DIOPTER, INTRAOCULAR LENS WAS STUCK IN 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; No Patient Involvement

  MAUDE report 8611917 ↗
• MalfunctionMay 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT ON (B)(6) 2019 A CC4204A, +20.0 DIOPTER, INTRAOCULAR LENS "CRACKED NOTICED UPON INSERTION." THERE WAS PATIENT CONTACT (LENS TOUCHED THE EYE). THE LENS WAS REMOVED AND A BACK-UP LENS IMPLANTED, A STITCH PLACED AT INCISION SITE WITHIN THE SAME SURGERY, ON (B)(6) 2019. CAUSE OF THE EVENT IS REPORTED AS INJECTOR FAILURE.

  Patient problems: No Code Available

  MAUDE report 8574101 ↗
• MalfunctionFeb 1, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CC4204A, +20.0 DIOPTER, INTRAOCULAR LENS, TORE DURING PROCEDURE. WHEN INJECTED THE DOCTOR NOTICED THAT THE LENS WAS TORN, CAUSE IS UNKNOWN. THERE WAS PATIENT CONTACT BUT NO INJURY. A BACKUP LENS, SAME MODEL AND DIOPTER WAS IMPLANTED DURING PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8298872 ↗
• MalfunctionSep 6, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT, AS THE SURGEON WAS LOADING A CC4204A INTRAOCULAR LENS, DIOPTER +20.0, IN PREPARATION TO IMPLANT INTO THE PATIENT'S LEFT (OS) EYE, THE LENS "UNFOLDED INCORRECTLY" WHILE IN THE CARTRIDGE. THE LENS WAS IMPLANTED AND EXPLANTED INTRAOPERATIVELY. THIS OCCURRED ON (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7853008 ↗
• InjuryMay 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLETED LAF CARD FOR A CC4204A, +20.0 DIOPTER, INTRAOCULAR LENS WAS RETURNED BACK TO THE MANUFACTURER. NOTE ON THE LAF CARD INDICATED "EXPLANTED". NURSE AT THE FACILITY STATED THAT SHE COULD NOT FIND ANY INFORMATION ON THIS LENS, THERE WAS NO DOCUMENTATION. THE ONLY INFORMATION AVAILABLE WAS THAT A THREE PIECE LENS WAS USED INSTEAD. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: No Code Available

  MAUDE report 7535153 ↗
• MalfunctionAug 24, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT A CC4204A LENS, +20.0 DIOPTER, WAS DAMAGED WHILE THE SURGEON WAS LOADING IT ON (B)(6) 2017. ATTEMPTS AT OBTAINING ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6818698 ↗
• MalfunctionAug 2, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT AS THE SURGEON WAS IMPLANTING A (B)(4) IMPLANTABLE COLLAMER LENS, DIOPTER +20.0 INTO THE PATIENT'S RIGHT EYE (OD), THE LENS TORE/BROKE. THE REPORTER STATED THAT NOTHING UNUSUAL OCCURRED DURING THE SURGERY AND AN EXPERIENCED TECHNICIAN PERFORMED THE PROCEDURE. THE LENS WAS EXCHANGED DURING THE SAME SURGERY. THE PROBLEM WAS RESOLVED. THIS OCCURRED ON (B)(6) 2017.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6762438 ↗
• MalfunctionJun 29, 2017Positioning Failure; Device Operates Differently Than Expected; Positioning Failure; Device Operates Differently Than Expected

  THE CUSTOMER STATED THE SURGEON WAS ADVANCING A CC4204A COLLAMER SINGLE PIECE LENS, +20.0 DIOPTER, IN THE CARTRIDGE AND THE PLUNGER OVERRODE AND DAMAGED THE LENS. THERE WAS NO PATIENT CONTACT. THE BACKUP LENS WAS IMPLANTED WITH NO PROBLEM, USING ANOTHER NANOPOINT INJECTOR SYSTEM. THE REPORTER STATED THE LENS DAMAGE WAS DUE TO THE NANOPOINT INJECTOR FAILED TO PERFORM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6679080 ↗
• MalfunctionMar 15, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED A CC4204A COLLAMER SINGLE PIECE LENS, +20.0 DIOPTER, WAS DAMAGED AND THERE WAS NO PATIENT CONTACT. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS UNKNOWN AND THE SURGEON CONVERTED TO A THREE PIECE LENS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6408304 ↗
• MalfunctionDec 6, 2016Device 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 STATED THE SURGEON IMPLANTED A CC4204A COLLAMER SINGLE PIECE LENS, +20.0 DIOPTER, BUT THE SURGEON DID NOT LIKE THE WAY THE LENS WAS LAYING IN THE PATIENT'S EYE, SO THE LENS WAS REMOVED. THE LENS WAS REPLACED WITH ANOTHER LENS. THERE WAS NO PATIENT INJURY. 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 6150076 ↗
• InjuryJun 22, 2016Material Opacification; Material Opacification

  THE REPORTER STATED THE SURGEON INSERTED A CC4204A COLLAMER SINGLE PIECE LENS, +20.0 DIOPTER, AND THE SURGEON NOTED, LOOKING AT THE LENS UNDER THE MICROSCOPE, THE LENS APPEARED "CLOUDY." THE LENS WAS REMOVED WITHIN THE SAME SURGERY WITH NO PATIENT INJURY AND THE BACKUP LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED. A SUTURE WAS REQUIRED TO CLOSE THE INCISION. THE REPORTER STATED THE CLOUDINESS OF THE LENS WAS NOT APPARENT PRIOR TO INSERTION. THE REPORTER STATED THEY FELT THE LENS WAS DEFECTIVE.

  Patient problems: No Code Available

  MAUDE report 5743529 ↗
• MalfunctionFeb 26, 2016Break; Break

  THE REPORTER INDICATED THE SURGEON IMPLANTED A CC4204A +20.00 DIOPTER COLLAMER SINGLE PIECE LENS IN THE PATIENT'S RIGHT EYE. LENS TORN WHILE LOADING, BUT NOT NOTED UNTIL LENS WAS PUT IN EYE. THE LENS WAS REMOVED, THE INCISION WAS NOT ENLARGED. BACKUP LENS, SAME MODEL AND SIZE WAS IMPLANTED. NO SUTURE REQUIRED. THERE WAS NO PATIENT INJURY. CAUSE OF LENS TEAR WAS LOADING ERROR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5464812 ↗
• InjuryFeb 25, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON ATTEMPTED TO IMPLANTED A CC4204A +20.00 DIOPTER COLLAMER SINGLE PIECE LENS IN THE PATIENT'S LEFT EYE. THE CAPSULE RUPTURED PRIOR TO INSERTING THE NANOFLEX LENS. THE LENS WAS INSERTED HALF WAY WHEN THE SURGEON SAW THAT IT WAS NOT GOING TO HOLD THE LENS, DECIDED NOT TO USE IT AND REMOVED THE LENS. THE SURGEON DECIDED TO IMPLANT A 3-PIECE LENS. IT WAS A SMALL CAPSULE TEAR AND NO VITECTOMY PERFORMED. THE LENS HAD NOTHING TO DO WITH THE RUPTURED CAPSULE. THE PATIENT'S VISION OUTCOME IS GREAT.

  Patient problems: Capsular Bag Tear

  MAUDE report 5461757 ↗
• MalfunctionFeb 19, 2016Torn Material; Torn Material

  THE REPORTER INDICATED THE SURGEON IMPLANTED A CC4204A +20.00 DIOPTER COLLAMER SINGLE PIECE LENS IN THE PATIENT'S RIGHT EYE. THE LENS TORE ON INSERTION. LENS WAS REMOVED AND BACKUP LENS, SAME MODEL AND SIZE WAS IMPLANTED. THERE WAS NO PATIENT INJURY. A NEW SCRUB TECH LOADED THE LENS IN WRONG (MTC-60C FP) CARTRIDGE IN ERROR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5448836 ↗

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