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

Model Number	CC4204A
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Vitrectomy (2643); No Code Available (3191)
Date of Event	07/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device name: collamer® ultraviolet-absorbing posterior chamber single piece foldable intraocular lens (b)(4).Results code(s): (operational problem): visual inspection of the returned product found the lens optic and both haptics torn, with a piece of haptic torn off and missing.The lens was returned in liquid.(b)(4).
Event or Problem Description
The reporter indicated the surgeon inserted a cc4204a collamer single piece lens +24.5 diopter, and the lens turned sideways in the patient's eye.The capsule was torn and the lens was removed.A vitrectomy was performed and a three piece lens was implanted.
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: 5909066
• Report Number: 2023826-2016-01155
• Device Sequence Number: 456587
• Product Code: HQL
• UDI-Device Identifier: 00841542102483
• UDI-Public: (01)00841542102483(17)180531
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/02/2016

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: 05/31/2018
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2016
• Supplement Report FDA Received Date: 09/14/2016
• 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
• Patient Age: 62 YR