Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204A (UDI 00841542102483)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00841542102483), received between Jun 27, 2016 and Dec 30, 2019 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER STATES THAT AS THE SURGEON REMOVED A CC4204A INTRAOCULAR LENS, DIOPTER +24.5 FROM THE BOTTLE, IT TORE. THERE WAS NO PATIENT CONTACT WITH THE LENS. THIS OCCURRED ON (B)(6) 2019. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Patient Involvement

  MAUDE report 9532325 ↗
• MalfunctionSep 20, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CC4204A, +24.50 DIOPTER, INTRAOCULAR LENS WAS IMPLANTED, REMOVED AND REPLACED WITH THE BACKUP LENS WITHIN THE SAME SURGERY DUE TO IT TEARING AT FOLD LINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7895683 ↗
• MalfunctionMar 13, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT, AS THE SURGEON WAS IMPLANTING A CC4204A INTRAOCULAR LENS, DIOPTER +24.5, INTO THE PATIENT'S LEFT (OS) EYE, THE LENS TORE. INTRA-OPERATIVELY, THE LENS WAS SUCCESSFULLY REMOVED AND REPLACED WITH AN ALTERNATE LENS. THE DATE OF SURGERY WAS (B)(6) 2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7336754 ↗
• InjuryJul 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT A CC4204A COLLAMER SINGLE PIECE LENS, +24.5 DIOPTER, CREATED POSTERIOR CAPSULE RUPTURE WITHOUT VITREOUS LOSS. THE POSTERIOR RUPTURE WAS NOTICED DURING LENS INSERTION, NO VITRECTOMY WAS PERFORMED SINCE THERE WAS NO VITREOUS LOSS. THE REPORTER STATED THAT THERE WAS NO PATIENT INJURY. A DIFFERENT MODEL LENS WAS IMPLANTED WITH NO ISSUES.

  Patient problems: Capsular Bag Tear; No Consequences Or Impact To Patient

  MAUDE report 6712661 ↗
• InjuryMar 15, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THE SURGEON INSERTED AND REMOVED A CC4204A COLLAMER SINGLE PIECE LENS, +24.5 DIOPTER, DURING THE SAME SURGERY DUE TO A DEFECTIVE LENS. A VITRECTOMY WAS PERFORMED AND THE INCISION WAS ENLARGED TO REMOVE THE LENS. A THREE PIECE LENS WAS IMPLANTED AND 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; Vitrectomy

  MAUDE report 6408303 ↗
• MalfunctionFeb 27, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT A (B)(4), +24.5 DIOPTER, LENS WAS OPENED ON A STERILE FIELD AND THE SURGEON DECIDED TO GO WITH A DIFFERENT POWER. THE REPORTER STATED THERE WAS NO PATIENT CONTACT AND SHE DID NOT KNOW THE CAUSE OF THE DAMAGED LENS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6362802 ↗
• InjuryAug 26, 2016Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THE SURGEON INSERTED A CC4204A COLLAMER SINGLE PIECE LENS +24.5 DIOPTER, AND THE LENS TURNED SIDEWAYS IN THE PATIENT'S EYE. THE CAPSULE WAS TORN AND THE LENS WAS REMOVED. A VITRECTOMY WAS PERFORMED AND A THREE PIECE LENS WAS IMPLANTED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 5909066 ↗
• MalfunctionJun 27, 2016Torn Material; Torn Material

  THE REPORTER STATED THE SURGEON WAS INSERTING THE CC4204A COLLAMER SINGLE PIECE LENS +24.5 DIOPTER AND THE LENS WAS NOTED TO BE DAMAGED. THE CAUSE OF THE LENS DAMAGE WAS DUE TO TECHNICIAN ERROR. THERE WAS PATIENT CONTACT WITH THE LENS, AND NO PATIENT INJURY. THE BACK UP LENS WAS USED WITH OUT INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5751996 ↗

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