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	11/25/2019
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 the lens vial.Visual inspection found that the optic and haptic were torn.No similar complaint type events reported for units within the same lot.
Event or Problem Description
A cc4204a intraocular lens, diopter +18.5 was returned as opened and not used.However, once received, it was noted that there is a tear on it.Attempts to obtain additional information have not been successful.
Additional Manufacturer Narrative
Corrected data: b3 - (b)(6) 2019 should be removed as it is not applicable.Claim#: (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: 9587401
• Report Number: 2023826-2020-00106
• Device Sequence Number: 11597501
• Product Code: HQL
• UDI-Device Identifier: 00841542102360
• UDI-Public: 00841542102360
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2019

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: 06/30/2020
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR