Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204A (UDI 00841542102438)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00841542102438), received between Jun 1, 2016 and Nov 3, 2020 — classified as 2 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (9 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2020No Apparent Adverse Event; No Apparent Adverse Event

  INFORMATION REGARDING A CC4204A INTRAOCULAR LENS, DIOPTER +22.0 WASRECEIVED WITH "DIDN'T LOAD RIGHT. WASTED" RECORDED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10779835 ↗
• MalfunctionFeb 21, 2020Off-Label Use; No Apparent Adverse Event; Off-Label Use; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CC4204A, +22.0 DIOPTER, INTRAOCULAR LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2020. "LENS WAS CRACKED/DAMAGED, BUT IT WAS UNCLEAR IF LENS WAS CRACKED PRIOR TO BEING IMPLANTED." NO PATIENT INJURY. BACK-UP LENS WAS IMPLANTED. THE LENS IMPLANTED, REMOVED, AND REPLACED INTRAOPERATIVELY. CAUSE OF THE EVENT IS REPORTED AS TECHNICIAN LOADING ERROR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9741508 ↗
• MalfunctionDec 19, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A CC4204A COLLAMER SINGLE PIECE LENS, +22.0 DIOPTER, WAS BROKEN AND IT WAS UNKNOWN IF THERE WAS ANY PATIENT CONTACT. 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; No Patient Involvement

  MAUDE report 9492207 ↗
• MalfunctionNov 13, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CC4204A INTRAOCULAR LENS, DIOPTER +22.0 WAS BROKEN DURING INJECTION AND WAS THEN THROWN AWAY. THIS OCCURRED ON (B)(6) 2019. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9317920 ↗
• MalfunctionSep 19, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON (B)(6) 2019 A CC4204A, +22.0 DIOPTER, INTRAOCULAR LENS TORE 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 9088380 ↗
• MalfunctionJun 11, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CC4204A, +22.00 DIOPTER, INTRAOCULAR LENS MALFUNCTIONED. IT WAS REPORTED THAT THERE WERE NO COMPLICATIONS AND NO SUTURES. 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; No Patient Involvement

  MAUDE report 8687576 ↗
• MalfunctionMar 25, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CC4204A, +22.0 DIOPTER, INTRAOCULAR LENS WAS DAMAGED DURING INSERTION INTO THE EYE. THE LENS WAS IMPLANTED AND REMOVED FROM EYE DURING INITIAL SURGERY ON (B)(6) 2019 WITH NO PATIENT INJURY. BACKUP LENS WAS IMPLANTED AND RESOLVED PROBLEM. REPORTER STATED THAT THE CAUSE OF EVENT WAS DUE CARTRIDGE ISSUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8447829 ↗
• InjuryMar 22, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THE SURGEON IMPLANTED A CC4204A COLLAMER SINGLE PIECE LENS, +22.0 DIOPTER, IN THE PATIENT'S EYE ON (B)(6) 2018. AT THE PATIENT'S POST-OP APPOINTMENT THE SURGEON NOTED A CRACK IN THE LENS OPTIC. THE LENS WAS EXPLANTED AND EXCHANGED ON (B)(6) 2018 WITH A DIFFERENT MODEL LENS. THERE WAS NO PATIENT INJURY. THE REPORTER STATED THE CAUSE OF THE LENS DAMAGE WAS UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 7364198 ↗
• MalfunctionMar 7, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT THE SURGEON PARTIALLY INJECTED A CC4204A COLLAMER SINGLE PIECE LENS, +22.0 DIOPTER, IN THE PATIENT'S EYE. THE SURGEON DID NOT LIKE HOW THE LENS WAS LOOKING SO HE REMOVED IT AND IMPLANTED THE BACKUP LENS. THERE WAS NO PATIENT INJURY. THE REPORTER STATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7322107 ↗
• MalfunctionJun 12, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT A CC4204A, +22.0 DIOPTER, COLLAMER SINGLE PIECE INTRAOCULAR LENS RIPPED DURING THE LOADING PROCESS BECAUSE OF THE INJECTOR. THE REPORTER STATED THAT THEY DISCARDED THE LENS AND RETURNED THE EMPTY BOX TO THE MANUFACTURER. THERE WAS NO PATIENT CONTACT. THE NANOPOINT INJECTOR WAS USED.

  Patient problems: No Patient Involvement

  MAUDE report 6635705 ↗
• InjuryMay 17, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT A CC4204A, +22.0 DIOPTER, SINGLE PIECE COLLAMER LENS TORE DURING INSERTION INTO THE PATIENT'S RIGHT EYE. THE LENS WAS REMOVED AND REPLACED WITH THE BACKUP LENS. THERE WAS AN ENLARGEMENT OF THE INCISION AND NO SUTURES WERE USED. THE REPORTER STATED THE NANOPOINT INJECTION SYSTEM WAS USED.

  Patient problems: No Code Available

  MAUDE report 6573221 ↗
• MalfunctionMay 9, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED THE HAPTIC OF A CC4204A COLLAMER SINGLE PIECE LENS, +22.0 DIOPTER, BROKE AND THE LENS WAS NOT IMPLANTED. THE CUSTOMER REPORTED THE LENS WAS DEFECTIVE. 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 6556156 ↗
• MalfunctionMay 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A CC4204A COLLAMER SINGLE PIECE LENS, +22.0 DIOPTER, WAS NOT IMPLANTED DUE TO SCRUB TECH ERROR. 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 6556155 ↗
• MalfunctionMar 16, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT WHEN INSERTING A CC4204A, +22.0 DIOPTER, SINGLE PIECE COLLAMER LENS, INTO THE LOADER, THE LENS BENT OVER ITSELF AND TORE WHEN IT WAS ADVANCED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6411217 ↗
• MalfunctionJan 26, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THE SURGEON INSERTED A CC4204A COLLAMER SINGLE PIECE LENS, +22.0 DIOPTER, AND THE LENS TORE. THE LENS WAS REMOVED WITH NO PATIENT INJURY, NO ENLARGED INCISION OR SUTURES. THE REPORTER INDICATED ANOTHER MANUFACTURERS LENS WAS IMPLANTED. THE REPORTER INDICATED THE EVENT MAY HAVE POSSIBLY BEEN DUE TO OPERATOR ERROR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6281926 ↗
• MalfunctionJan 20, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED A (B)(4) COLLAMER SINGLE PIECE LENS, +22.0 DIOPTER, WAS TORN IN THE INJECTOR, DURING THE LOADING PROCESS. 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 6267545 ↗
• MalfunctionDec 15, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER STATED THE SURGEON INSERTED AND REMOVED A CC4204A COLLAMER SINGLE PIECE LENS, +22.0 DIOPTER, WITHIN THE SAME SURGERY, DUE TO CHANGING HIS MIND FOR A SMALLER DIOPTER LENS. THERE WAS NO PATIENT INJURY, NO ENLARGED INCISION OR SUTURES. THE REPORTER STATED THE CAUSE OF THE EVENT WAS SURGEONS DECISION AND THERE WAS NO ISSUE WITH THE LENS OR INJECTOR SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6176011 ↗
• MalfunctionNov 17, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THE SURGEON ATTEMPTED TO INSERT A CC4204A COLLAMER SINGLE PIECE LENS, +22.0 DIOPTER, AND THE LENS TORE. THERE WAS 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 6111710 ↗
• MalfunctionOct 17, 2016Torn Material; Torn Material

  THE REPORTER INDICATED THE SURGEON ATTEMPTED TO IMPLANT A CC4204A SINGLE-PIECE COLLAMER LENS, +22.0 DIOPTER, IN THE PATIENT'S EYE ON (B)(6) 2016. THE SURGICAL TECHNICIAN LOADED THE LENS AND THE LENS TORE IN HALF-DOWN THE MIDDLE. NO DEFECTS WERE NOTICED. THE REPORTER COULD NOT CONFIRM "USER ERROR". THE SURGEON USED THE BACKUP LENS. NO PATIENT CONTACT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6034388 ↗
• MalfunctionJun 1, 2016Split; Split

  THE REPORTER STATED THE SURGEON INSERTED A CC4204A COLLAMER SINGLE PIECE LENS, +22.0 DIOPTER, AND THE LENS SPLIT IN TWO AFTER INSERTION INTO THE EYE. THE LENS WAS REMOVED WITH NO PATIENT INJURY AND THE BACKUP LENS WAS IMPLANTED. THE CAUSE OF THE EVENT WAS DUE TO THE LENS WAS LOADED INCORRECTLY BY THE SCRUB TECHNICIAN. THE FACILITY DISCARDED THE LENS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5693634 ↗

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