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

Model Number	AQ5010V
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brand name: silicone ultraviolet-absorbing posterior chamber three piece foldable intraocular lens (elastimide®).(b)(4).Method: lens work order search, lens evaluation.Results: a lens work order search revealed no similar complaint within the work order.Visual inspection of the returned product found the lens in three pieces.The optic is torn and piece of optic and one loop haptic is tor off.There was evidence of dry clear surgical residue on optic surface.Conclusions: based on the complaint history, lens work order and evaluation of returned product, it was determined that the root cause of this event was due to loading error.(b)(4).
Event or Problem Description
The reporter indicated the surgeon inserted an aq5010v +01.00 diopter three piece silicone lens.The lens was not folded correctly during loading.The physician tried to remove and refold the lens to reload, however lens would not fold properly.When they tried to implant the lens, it tore.Lens was partially in the eye.Lens was removed with no patient injury.Cause of this incident was due to loading error by the surgical tech.
Additional Manufacturer Narrative
Method code(s): (process evaluation): device history record review result code(s): (operational problem) : 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
Method: (process evaluation): device history record review.Result: (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).

• 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: 5553062
• Report Number: 2023826-2016-00422
• Device Sequence Number: 10858815
• Product Code: HQL
• UDI-Device Identifier: 00841542101288
• UDI-Public: (01)00841542101288(17)200229
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/08/2016

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: 02/29/2020
• Device Model Number: AQ5010V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/08/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/06/2016
• Supplement Report FDA Received Date: 06/08/2016; 08/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR