MAUDE Adverse Event Report: STAAR SURGICAL COMPANY SEE H10; INTRAOCULAR LENS

Model Number	CC4204A +20.5
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical product: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.The lens was returned in liquid in the lens case/vial.There was clear surgical residue on the product and lens surface.Visual inspection found tears in the optic.No similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
A cc4204a intraocular lens, diopter +20.5 was returned with tears on the lens.Attempts to obtain additional information have not been successful.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Additional information: the reporter states the lens was opened in error.The surgeon elected to use a different lens.No patient contact, no product malfunction alleged.(b)(4).

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 7873516
• Report Number: 2023826-2018-01378
• Device Sequence Number: 19329102
• Product Code: HQL
• UDI-Device Identifier: 00841542102407
• UDI-Public: 00841542102407
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/17/2018

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: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: CC4204A +20.5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 10/02/2018; 11/06/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 10/23/2018; 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR