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

Model Number	AQ2010V
Medical Device Problem Codes	Fracture (1260); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Diopter +24.00.Silicone ultraviolet-absorbing posterior chamber three piece foldable intraocular lens (elastimide®).(b)(4).Visual inspection of the returned product found the lens optic torn in half.Piece of optic and one loop haptic is torn off and missing.Lens was returned dry.There was evidence of dry clear residue on optic surface.A lens work order search was performed and no similar complaint was found.(b)(4).
Event or Problem Description
The reporter indicated the surgeon inserted an aq2010v +24.00 diopter three piece silicone lens.Lens loaded and injected, lens ripped - the haptic got caught in the injector.Lens was completely removed from the eye.A new lens was implanted without difficulty.No patient injury.
Additional Manufacturer Narrative
Method: device history record review, medical review.Results: upon review of the device history record, there is nothing in the manufacturing, inspection and packaging process records that suggests a contributory factor in the complaint.Per medical review - reportedly, haptic of a 3-piece silicone iol was "caught in the injector" during insertion, causing the tear that required intraoperative lens removal/exchange.No reported incision enlargement or any other tissue damage.Report, dated on 12/16/15, stated that there was no patient injury during lens removal and that backup lens was implanted.No reported postoperative sequelae.Conclusion: based on the complaint history, work order search, product evaluation, medical review, and device history record review, a specific root cause of the event could not be determined.(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: 5368880
• Report Number: 2023826-2016-00010
• Device Sequence Number: 235903
• Product Code: HQL
• UDI-Device Identifier: 00841542100304
• UDI-Public: (01)00841542100304(17)190930
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P900048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Followup
• Report Date (Section B): 12/15/2015

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: 09/30/2019
• Device Model Number: AQ2010V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2016
• Supplement Report FDA Received Date: 02/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1