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

Model Number	CC4204A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/16/2016
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 no visible damage to the lens.The lens was returned in liquid.Conclusions code(s): (unable to confirm complaint): based on the complaint history, work order search and product evaluation, a specific root cause of the event could not be determined.(b)(4).
Event or Problem Description
The reporter stated the surgeon inserted a cc4204a collamer single piece lens, +23.5 diopter, and the capsule tore.The lens was removed and another lens was implanted.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: 5898595
• Report Number: 2023826-2016-01157
• Device Sequence Number: 521765
• Product Code: HQL
• UDI-Device Identifier: 00841542102469
• UDI-Public: (01)00841542102469(17)171231
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/26/2016

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: 12/31/2017
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2016
• Initial Report FDA Received Date: 08/23/2016
• 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: 84 YR