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

Model Number	CC4204A
Medical Device Problem Code	Split (2537)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2016
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, lens discarded.(b)(4).
Event or Problem Description
The reporter stated the surgeon inserted a cc4204a collamer single piece lens, +22.0 diopter, and the lens split in two after insertion into the eye.The lens was removed with no patient injury and the backup lens was implanted.The cause of the event was due to the lens was loaded incorrectly by the scrub technician.The facility discarded the lens.
Additional Manufacturer Narrative
Method code(s): (process evaluation): device history record review.Result code(s): (no failure detected): based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within the established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.The cause of the event was due to the lens was loaded incorrectly by the scrub technician.(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: 5693634
• Report Number: 2023826-2016-00798
• Device Sequence Number: 16190549
• Product Code: HQL
• UDI-Device Identifier: 00841542102438
• UDI-Public: (01)00841542102438(17)170831
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup
• Report Date (Section B): 05/10/2016

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: 08/31/2017
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2016
• Supplement Report FDA Received Date: 10/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR