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

Model Number	CC4204A
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brand name: collamer® ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Device evaluated by manufacturer: no - 81 (other): lens not returned.(b)(4).
Event or Problem Description
The reporter stated the surgeon said the cc4204a collamer single piece lens +19.0 diopter became caught on the way out of the injector and tore upon insertion.The lens was cut to remove from the eye.There was no patient injury and no incision enlargement or sutures.The back up lens was used with out incident.

• 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: 5800364
• Report Number: 2023826-2016-00840
• Device Sequence Number: 10895093
• Product Code: HQL
• UDI-Device Identifier: 00841542102377
• UDI-Public: (01)00841542102377(17)180228
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/15/2016

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: 02/28/2018
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2016
• Initial Report FDA Received Date: 07/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR