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 Patient Involvement (2645)
Date of Event	06/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brand name: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.No similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
A cc4204a intraocular lens, diopter +22.5 was requested to be returned.Reporter states the lens has a bent haptic and there was no patient contact with the lens.Attempts to obtain additional information have not been successful.
Additional Manufacturer Narrative
Device evaluation: the lens was returned stuck in the cartridge.The cartridge was returned in a lens case.Visual inspection of the lens found it was returned in the cartridge.Visual inspection of the cartridge found no visible damage to the device and the lens stuck inside.Claim#: (b)(4).
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Date of report corrected to 26 jun 2019 in initial mdr.Date received by manufacturer corrected to 26 jun 2019 in initial mdr.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: 8795452
• Report Number: 2023826-2019-01234
• Device Sequence Number: 16599887
• Product Code: HQL
• UDI-Device Identifier: 00841542102445
• UDI-Public: 00841542102445
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/26/2019

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: 10/31/2020
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 07/01/2019; 07/24/2019; 10/01/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 07/30/2019; 09/12/2019; 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INJ SYSTEM MODEL: NANOPOINT, INJ SYSTEM LOT# UNK