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); Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brand name: silicone ultraviolet-absorbing posterior chamber three piece foldable intraocular lens (elastimide®).Results: (operational problem): visual inspection of the returned product found the lens was torn into two pieces.The lens was returned dry and there was evidence of surgical residue.(b)(4).
Event or Problem Description
The reporter stated the surgeon inserted the aq2010v silicone three piece lens +12.0 diopter and the lens was noted to be damaged.The lens was removed and no patient injury was reported.The back up lens, same model was used with out incident.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
2017 is incorrect.Complaint information does not suggest improper or incorrect procedure or method.(b)(4).
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter provided additional information, there was no incision enlargement but sutures were used and the back up lens was implanted.

• 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: 5814077
• Report Number: 2023826-2016-00964
• Device Sequence Number: 346855
• Product Code: HQL
• UDI-Device Identifier: 00841542100069
• UDI-Public: (01)00841542100069(17)200131
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2016

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: 01/31/2020
• Device Model Number: AQ2010V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/24/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/21/2016
• Supplement Report FDA Received Date: 12/13/2016; 12/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR