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

Model Number	AQ5010V
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Diopter: +4.00.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.Conclusion: based on the complaint history and work order search, a specific root cause of the event could not be determined.(b)(4).
Event or Problem Description
The reporter stated the surgeon used an aq5010v +4.00 diopter three piece silicone lens.As the surgeon was going to insert.The lens, the lens cracked in the cartridge.The lens was not used.There was no patient contact.The lens is defective.Another same model lens was implanted.
Additional Manufacturer Narrative
Method: (process evaluation): device history record review.Result: (operational problem) : visual inspection of the returned product found no visible damage; (no failure detected): based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within the established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.(b)(4).
Additional Manufacturer Narrative
Visual inspection of the returned product found a piece of the lens optic and one haptic torn off and missing.The lens was returned dry and there was evidence of clear surgical residue.Based on the complaint history, work order search and the product evaluation, a specific root cause of the event could not be determined.(b)(4).
Additional Manufacturer Narrative
(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: 5525104
• Report Number: 2023826-2016-00291
• Device Sequence Number: 395857
• Product Code: HQL
• UDI-Device Identifier: 00841542101349
• UDI-Public: (01)00841542101349(17)191231
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P900048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/23/2016

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: 12/31/2019
• Device Model Number: AQ5010V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/23/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 03/24/2016
• Supplement Report FDA Received Date: 08/24/2016; 09/13/2016; 10/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1