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

Model Number	AQ5010V
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Diopter: +04.00.Silicone ultraviolet-absorbing posterior chamber three piece foldable intraocular lens (elastimide®).Device evaluated by manufacturer? no.Lens not returned.Evaluation method: lens work order search.Evaluation results: a lens work order search revealed no similar complaint within the work order.Performed a claim search by cartridge and injector lot number and no similar complaints were found.Conclusions: based on the complaint history, it was determined that the root cause of this event was due to loading error.(b)(4).
Event or Problem Description
The reporter stated the surgeon implanted an aq5010v +04.00 diopter three piece silicone lens.Lens tore during insertion into the eye.The lens was removed without any injury to patient.Another lens, same model and size was implanted.Cause of lens tear was loading error by the tech, it was the first time the tech loaded this model.There was no problem loading the second lens.
Additional Manufacturer Narrative
Based on the results of the investigation, nothing was found in the manufacturing, inspection and packaging process records to suggest a contributory factor to the complaint.(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: 5472445
• Report Number: 2023826-2016-00115
• Device Sequence Number: 18916918
• Product Code: HQL
• UDI-Device Identifier: 00841542101349
• UDI-Public: (01)00841542101349(17)200630
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Report Date (Section B): 02/02/2016

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: 06/30/2020
• Device Model Number: AQ5010V
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2016
• Supplement Report FDA Received Date: 08/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR