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

Model Number	CC4204A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Diopter: +20.00.Concomitant: collamer® ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.(b)(4).Method: evaluation method: lens work order search.Results: evaluation results: a lens work order search revealed no similar complaint within the work order.Visual inspection of the returned product found half of optic and half of one plate haptic remain.One whole and half of plate haptic along with half of optic is torn off and missing.Lens was returned in liquid.Conclusions: (user error caused or contributed to event): based on the complaint history, work order search and the evaluation of the 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 implanted a cc4204a +20.00 diopter collamer single piece lens in the patient's right eye.Lens torn while loading, but not noted until lens was put in eye.The lens was removed, the incision was not enlarged.Backup lens, same model and size was implanted.No suture required.There was no patient injury.Cause of lens tear was loading error.
Additional Manufacturer Narrative
Correction: a lens work order search revealed there was one similar complaint within the work order.(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: 5464812
• Report Number: 2023826-2016-00203
• Device Sequence Number: 10882218
• Product Code: HQL
• UDI-Device Identifier: 00841542102391
• UDI-Public: (01)00841542102391(17)171031
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• 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): 01/29/2016

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: 10/31/2017
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2016
• Supplement Report FDA Received Date: 05/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR