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

Model Number	CQ2015A
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device name: collamer® ultraviolet-absorbing posterior chamber three piece foldable intraocular lens.Device evaluated by manufacturer? no - lens not returned.(b)(4).
Event or Problem Description
The reporter stated the surgeon inserted the cq2015a collamer three piece lens +21.0 diopter and the lens was noted to be damaged.The lens was removed with out patient injury.The back up lens was used.The cause of the lens damage was due to technician error.
Additional Manufacturer Narrative
(b)(4) is incorrect.There was no torn material due to a material integrity issue.Visual inspection of the returned product found the lens optic had multiple tears and one loop haptic was missing.The lens was returned in liquid.(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: 5850825
• Report Number: 2023826-2016-01011
• Device Sequence Number: 13759769
• Product Code: HQL
• UDI-Device Identifier: 00841542102001
• UDI-Public: (01)00841542102001(17)180228
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2016

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: CQ2015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2016
• Supplement Report FDA Received Date: 12/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR