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 Code Available (3191)
Date of Event	04/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device: collamer® ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.(b)(4).Results: (evaluation result): visual inspection of the returned product found the lens was torn into two pieces.Both haptics were torn, with pieces missing.(b)(4).
Event or Problem Description
The reporter stated the surgeon inserted a cc4204a single-piece collamer lens, +24.0 diopter, in the patient's eye and one end of the lens was cut.The lens was cut in half to remove from the eye within the same surgery.The backup lens was implanted and one suture was used to close the wound.The reporter stated the cause of the event was the surgeon loaded the lens incorrectly and there was no device malfunction.
Additional Manufacturer Narrative
(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: 5685246
• Report Number: 2023826-2016-00767
• Device Sequence Number: 195436
• Product Code: HQL
• UDI-Device Identifier: 00841542102476
• UDI-Public: (01)00841542102476(17)171130
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/29/2016

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: 11/30/2017
• Device Model Number: CC4204A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2016
• Supplement Report FDA Received Date: 09/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR