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

Model Number	AA4203TL
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Silicone ultraviolet-absorbing posterior chamber single piece foldable intraocular lens (elastic®) with toric optic.Work order search: no similar claims were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter stated that aa4203tl, 17.5se/2.0 diopter, silicone single piece intraocular lens was implanted on (b)(6) 2016.It was explanted during the same surgery due to a tear in the lens.The backup lens was implanted with no issues.There was no reported enlargement of the incision and no patient injury.The reporter stated that the nurse felt like the doctor tore the lens when he was pushing it out of the injector and the cause was user error.

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6613239
• Report Number: 2023826-2017-00933
• Device Sequence Number: 18956345
• Product Code: HQL
• UDI-Device Identifier: 00841542100700
• UDI-Public: (01)00841542100700(17)170630
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P880091
• 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): 05/31/2017

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: 06/30/2017
• Device Model Number: AA4203TL
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2017
• Initial Report FDA Received Date: 06/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR