MAUDE Adverse Event Report: STAAR SURGICAL COMPANY SEE H-10; INTRAOCULAR LENS

Model Number	AQ2010V
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Compatibility Problem (2960); Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Silicone ultraviolet-absorbing posterior chamber three piece foldable intraocular lens (elastimide®).(b)(4).
Event or Problem Description
The reporter stated the aq2010v silicone three piece lens +20.0 diopter was partially inserted in the patient's eye on (b)(6) 2016 when the lens was clipped by the inserter, the lens was explanted on (b)(6) 2016 without patient injury.It was indicated that the cause of the lens damage was due to possible human error.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Additional information received.The facility reported a cq cartridge was used but this cartridge is not the recommended cartridge for the model lens used (b)(4).

• Brand Name: SEE H-10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6046694
• Report Number: 2023826-2016-01490
• Device Sequence Number: 13575030
• Product Code: HQL
• UDI-Device Identifier: 00841542100229
• UDI-Public: (01)00841542100229(17)181130
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P900048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2016

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: 11/30/2018
• Device Model Number: AQ2010V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/21/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/21/2016
• Supplement Report FDA Received Date: 12/13/2016; 02/03/2017
• 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: CARTRIDGE MODEL - LOT NUMBER UNK; INJECTOR MODEL - LOT NUMBER UNK
• Patient Age: 58 YR