Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204A (UDI 00841542102469)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00841542102469), received between Aug 23, 2016 and Sep 1, 2020 — classified as 3 injuries, 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2020Scratched Material; Scratched Material

  THE REPORTER INDICATED THAT THE A CC4204A, +23.5 DIOPTER, INTRAOCULAR LENS HAD A SCRATCH DUE TO INJECTOR. NO PATIENT CONTACT. 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 10477210 ↗
• MalfunctionJun 1, 2020No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON NOTICED A CC4204A, +23.5 DIOPTER, INTRAOCULAR LENS HAD A TEAR DURING LOADING. IT WAS REPORTED THAT THERE WAS PATIENT CONTACT BUT 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 Consequences Or Impact To Patient

  MAUDE report 10105277 ↗
• InjuryOct 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT WHEN TRYING TO IMPLANT A CC4204A, +23.5 DIOPTER, INTRAOCULAR LENS THE LENS SPLIT IN HALF WHEN INJECTING IT INTO THE EYE, HALF WENT IN AND HALF DIDNT. THE INCISION WAS ENLARGED SLIGHTLY TO REMOVED DAMAGED LENS AND THE BACKUP LENS WAS IMPLANTED WITH NO FURTHER ISSUES. 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 Code Available

  MAUDE report 9152207 ↗
• MalfunctionSep 19, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON (B)(6) 2019 A CC4204A, +23.5 DIOPTER, INTRAOCULAR LENS TORE IN HALF DURING LOADING (BEFORE INSERTION). IT WAS REPORTED THAT THERE WAS NO PATIENT CONTACT, NO PATIENT INJURY. BACK-UP LENS WAS IMPLANTED AND THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS INJECTOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9088379 ↗
• MalfunctionApr 16, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT, AS THE SURGEON LOADED A CC4204A INTRAOCULAR LENS, DIOPTER +23.5, IT TORE. IT WAS INJECTED INTO THE PATIENT'S EYE AND EXPLANTED INTRAOPERATIVELY. THIS OCCURRED ON (B)(6) 2019. "NO PATIENT INJURY" IS REPORTED. THE CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8519010 ↗
• MalfunctionJan 16, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A CC4204A COLLAMER SINGLE PIECE LENS, +23.5 DIOPTER, BECAME STUCK IN THE CARTRIDGE DURING THE LOADING PROCESS AND THERE WAS NO PATIENT CONTACT. THE BACKUP LENS WAS IMPLANTED WITH NO PROBLEM. THE REPORTER INDICATED THE CAUSE OF THE EVENT AND IF THE LENS WAS DAMAGED WAS UNKNOWN. THE REPORTER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: No Patient Involvement

  MAUDE report 8255283 ↗
• MalfunctionDec 13, 2018Mechanical Jam; Mechanical Jam

  THE REPORTER INDICATED THAT THE CC4204A, +23.5 DIOPTER, INTRAOCULAR LENS LOADED BUT WOULD NOT ADVANCE IN CARTRIDGE. IT WAS REPORTED THAT THERE WAS NO PATIENT CONTACT. IT WAS REPORTED THAT THERE WAS A LOADING ERROR THAT COULD HAVE BEEN CAUSED BY TRAINING A NEW SCRUB NURSE, BUT THERE IS NO CERTAINTY TO THE CAUSE OF THE EVENT. BACKUP LENS WAS INSERTED WITHOUT ANY REPORTED PROBLEMS. PATIENT IS DOING FINE.

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

  MAUDE report 8159569 ↗
• MalfunctionSep 6, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT, WHILE PREPARING TO IMPLANT A CC4204A INTRAOCULAR LENS, DIOPTER +23.5 INTO THE PATIENT'S EYE, THE LENS WAS DAMAGED DURING LOADING. REPORTEDLY, THERE WAS NO PATIENT CONTACT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Patient Involvement

  MAUDE report 7852999 ↗
• MalfunctionAug 29, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A CC4204A COLLAMER SINGLE PIECE LENS, +23.5 DIOPTER, WAS TORN DURING THE LOADING PROCESS AND THERE WAS NO PATIENT CONTACT. THE BACKUP LENS WAS IMPLANTED WITH NO PROBLEM. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7830749 ↗
• MalfunctionJul 24, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CC4204A, +23.5 DIOPTER, INTRAOCULAR LENS BENT UPON LOADING. DOCTOR LOADED LENS BUT AS IT WENT UP THE LOADER, IT STARTED TO BEND. NO PATIENT CONTACT. DISCARDED LENS, REPLACED WITH BACKUP LENS ISSUE RESOLVED. CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 7716195 ↗
• MalfunctionMar 21, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A CC4204A, +23.5 DIOPTER, INTRAOCULAR LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. DURING IMPLANTATION, THE SURGEON NOTICED THAT THE LENS TORE AS IT LEFT THE NOZZLE. THE LENS WAS EXCHANGED INTRAOPERATIVELY WITH A BACK-UP LENS AND IT WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7359038 ↗
• MalfunctionNov 29, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON ATTEMPTED TO IMPLANT A CC4204A, +23.5 DIOPTER, COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. WHILE LOADING THE LENS INTO THE CARTRIDGE, THE BACK PLATE OF THE LENS BROKE. IT WAS NOT IMPLANTED AND THERE WAS NO PATIENT CONTACT. A BACK-UP LENS WAS THEN IMPLANTED INTO THE PATIENT. NO OTHER ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7069170 ↗
• 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 +23.5, IN PREPARATION TO IMPLANT INTO THE PATIENT'S LEFT (OS) EYE, THE LENS TORE. REPORTEDLY, THERE WAS NO PATIENT CONTACT WITH THE LENS. ON THE RETURNED LENS BOX IS WRITTEN, "LENS RIPPED. DID NOT GO IN PATIENT." ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7033621 ↗
• MalfunctionNov 7, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT, AFTER THE SURGEON IMPLANTED A CC4204A INTRAOCULAR LENS, DIOPTER +23.5 INTO THE PATIENT'S LEFT EYE (OS), HE NOTICED A "NICK" ON THE LENS. THE LENS WAS EXCHANGED ANOTHER LENS, WITH NO PATIENT INJURY REPORTED. THIS OCCURRED ON (B)(6) 2017. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7006954 ↗
• InjuryJul 26, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A CC4204A COLLAMER SINGLE PIECE LENS, +23.5 DIOPTER, WITHIN THE SAME SURGERY. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND A VITRECTOMY WAS PERFORMED. THE LENS WAS NOT EXCHANGED FOR ANOTHER LENS. THE REPORTER INDICATED THE LENS WAS TORN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Blurred Vision; Capsular Bag Tear; Corneal Decompensation; Corneal Edema; No Code Available; Vitrectomy

  MAUDE report 6745615 ↗
• MalfunctionJan 13, 2017Device Operates Differently Than Expected; Device Damaged by Another Device; Device Operates Differently Than Expected; Device Damaged by Another Device

  THE REPORTER INDICATED A CC4204A COLLAMER SINGLE PIECE LENS, +23.5 DIOPTER, WAS DAMAGED BY THE INJECTOR DURING THE LOADING PROCESS. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS IMPLANTED. THE REPORTER INDICATED A POSSIBLE CAUSE OF THE EVENT WAS THE NANOPOINT INJECTOR SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6251938 ↗
• InjuryAug 23, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  THE REPORTER STATED THE SURGEON INSERTED A CC4204A COLLAMER SINGLE PIECE LENS, +23.5 DIOPTER, AND THE CAPSULE TORE. THE LENS WAS REMOVED AND ANOTHER LENS WAS IMPLANTED. SUTURES WERE REQUIRED. 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 Code Available

  MAUDE report 5898595 ↗

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