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

Model Number	AQ2010V
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/06/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Silicone ultraviolet-absorbing posterior chamber three piece foldable intraocular lens (elastimide®).Evaluation method: lens work order search, lens evaluation.Evaluation results: a lens work order search revealed no similar complaint within the work order.Visual inspection of the returned product found one loop haptic and piece of optic torn off and missing.There was evidence of dry clear surgical residue on optic surface.Conclusion: conclusion not yet available.Evaluation is in progress.(b)(4).
Event or Problem Description
The reporter indicated the surgeon inserted an aq2010v +05.00 diopter three piece silicone lens.The haptic broke during insertion into the patient's left eye.Lens was removed with no patient injury.No backup lens was available at the time.A lens was implanted two weeks later.Cause of broken haptic is unknown.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Device history record (dhr) review: upon review of the device history record, there is nothing 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: 5553045
• Report Number: 2023826-2016-00390
• Device Sequence Number: 520326
• Product Code: HQL
• UDI-Device Identifier: 00841542101226
• UDI-Public: (01)00841542101226(17)200630
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 06/30/2020
• Device Model Number: AQ2010V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/06/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/06/2016
• Supplement Report FDA Received Date: 09/09/2016; 10/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR