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

Model Number	CC4204A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Vitrectomy (2643); No Code Available (3191)
Date of Event	02/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Collamer® ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Device evaluation: visual inspection of the returned product found small tears on one haptic.The lens was returned in liquid.(b)(4).
Event or Problem Description
The reporter stated the surgeon inserted and removed a cc4204a collamer single piece lens, +24.5 diopter, during the same surgery due to a defective lens.A vitrectomy was performed and the incision was enlarged to remove the lens.A three piece lens was implanted and sutures were required.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.

• 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: 6408303
• Report Number: 2023826-2017-00338
• Device Sequence Number: 19028341
• Product Code: HQL
• UDI-Device Identifier: 00841542102483
• UDI-Public: (01)00841542102483(17)180831
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/14/2017

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: 08/31/2018
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2017
• Initial Report FDA Received Date: 03/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL NANOPOINT - LOT NUMBER UNK; INJECTOR MODEL NANOPOINT - LOT NUMBER UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR