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 Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that the surgeon noticed that the cc4204a, +22.5 diopter, intraocular lens tore while it was being loaded on (b)(6) 2017.There was not patient contact with the torn lens.A back-up lens, same size and same diopter, was used and it was successful.
Additional Manufacturer Narrative
Device evaluation: the lens was returned in liquid, in a lens vial.Visual inspection found there was a missing piece of haptic and the nano inserter was returned with the lens.(b)(4).
Additional Manufacturer Narrative
Claim #: (b)(4).
Additional Manufacturer Narrative
Work order search: no similar complaint type events were reported for units within the same lot.Claim # (b)(4).
Additional Manufacturer Narrative
Corrected data: device evaluation: should have been reported in mdr supplemental 1.Delivery system was returned in a device tray.Visual inspection found the plunger bent.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: 6856350
• Report Number: 2023826-2017-01428
• Device Sequence Number: 819941
• Product Code: HQL
• UDI-Device Identifier: 00841542102445
• UDI-Public: 00841542102445
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/17/2017

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: 01/31/2019
• 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: 09/07/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/17/2017
• Supplement Date Received by Manufacturer: 09/07/2017; 11/07/2017; 11/29/2017; 12/07/2017
• Initial Report FDA Received Date: 09/11/2017
• Supplement Report FDA Received Date: 10/02/2017; 11/07/2017; 11/29/2017; 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR