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

Model Number	CC4204A
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Collamer® ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Device evaluated by manufacturer? no.(b)(4).Lens not returned.
Event or Problem Description
The reporter stated the surgeon inserted a cc4204a collamer single piece lens, +20.0 diopter, and the surgeon noted, looking at the lens under the microscope, the lens appeared "cloudy." the lens was removed within the same surgery with no patient injury and the backup lens (same model and diopter) was implanted.A suture was required to close the incision.The reporter stated the cloudiness of the lens was not apparent prior to insertion.The reporter stated they felt the lens was defective.
Additional Manufacturer Narrative
Visual inspection of the returned product found the lens optic and both haptics torn, with a piece torn off and missing.The lens was returned in liquid.Based on the complaint history, work order search, medical review and product evaluation, 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: 5743529
• Report Number: 2023826-2016-00845
• Device Sequence Number: 16259832
• Product Code: HQL
• UDI-Device Identifier: 00841542102391
• UDI-Public: (01)00841542102391(17)180228
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 05/23/2016

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?: No
• Operator of Device: Physician
• Device Expiration Date: 02/28/2018
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/22/2016
• Supplement Report FDA Received Date: 10/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention