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

Model Number	CC4204A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brand name: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens the lens was returned in liquid, in a lens vial.Visual inspection found that only a portion of the lens was returned.No similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
A portion of cc4204a intraocular lens, diopter +21.5 was returned."misfire, pt contact" was recorded on the box.Attempts to obtain additional information have not been successful.

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8633165
• Report Number: 2023826-2019-00874
• Device Sequence Number: 13946871
• Product Code: HQL
• UDI-Device Identifier: 00841542102421
• UDI-Public: 00841542102421
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2019

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: 04/30/2019
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR