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

Model Number	CC4204A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
A cc4204a, +24.0 diopter, intraocular lens was returned damaged to the manufacturer.The reporter indicated that there was no patient contact with the lens.Additional information was unable to be provided.
Additional Manufacturer Narrative
Corrected data: device evaluation: the product was returned in liquid, in a lens case/vial.Visual inspection found the lens optic torn, the lens torn into two pieces, and missing a piece of haptic.Claim# (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: 7318881
• Report Number: 2023826-2018-00287
• Device Sequence Number: 13482633
• Product Code: HQL
• UDI-Device Identifier: 00841542102476
• UDI-Public: 00841542102476
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 09/30/2018
• 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: 02/06/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/06/2018
• Supplement Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1