MAUDE Adverse Event Report: STAAR SURGICAL COMPANY COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE IOL; INTRAOCULAR LENS

Model Number	CC4204A
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: product evaluation found that the lens was returned in liquid in a lens case/vial.Visual inspection found no visible damage to lens.(b)(4).Conclusion code: per dfu for this lens model, iol's are contraindicated of implantations of a lens in a patient under the age of 60 years old.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a cc4204a,+18.0 diopter, intraocular lens in the patient's left eye (os) on (b)(6) 2018.It was noticed that the lens "would not center", so the surgeon removed the lens ans exchanged it for a 3 piece staar lens.The surgeon used a 2.75 blade for the initial incision, but had to use suture to close it.No other details were provided.
Additional Manufacturer Narrative
Method: no additional similar complaint type events were found within the associated lot.Outcomes attributed to adverse event: it is corrected to "other serious (important medical events)" (b)(4).

• Brand Name: COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 7398190
• Report Number: 2023826-2018-00492
• Device Sequence Number: 11066742
• Product Code: HQL
• UDI-Device Identifier: 00841542102353
• UDI-Public: 00841542102353
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 12/31/2018
• Device Model Number: CC4204A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 54 YR