MAUDE Adverse Event Report: STAAR SURGICAL COMPANY SEE H10; INTRAOCULAR LENS

Model Number	CC4204A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Collamer® ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Work order search: no similar claim type was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter stated that a cc4204a, +26.0 diopter, implantable collamer lens was implanted and removed during the same surgery because the doctor didn't like the way the lens fit on the patient's eye.The doctor change to a different model lens.There was no enlargement of the incision or sutures used and no reported patient injury.
Additional Manufacturer Narrative
Returned product evaluation found lens was returned in liquid in a lens vial.Visual inspection found the optic torn/split; haptic torn/broken/bent/deformed; missing piece of haptic; len returned torn in four pieces.(b)(4).

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6599960
• Report Number: 2023826-2017-00802
• Device Sequence Number: 95179
• Product Code: HQL
• UDI-Device Identifier: 00841542102513
• UDI-Public: (01)00841542102513(17)180531
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2017

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: 05/31/2018
• 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: 05/31/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/30/2017
• Supplement Report FDA Received Date: 06/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR