MAUDE Adverse Event Report: STAAR SURGICAL COMPANY AG SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL; INTRAOCULAR LENS

Model Number	AA4203TL
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lens was returned dry, in lens case.Visual inspection found the optic torn, damage to the haptic, and orange/red dry foreign material on the lens surface.(b)(4).
Event or Problem Description
The reporter stated that the surgeon implanted and explanted an (b)(4) toric lens, 20.5 diopter, on the same day and replaced it with a different lens.The reporter stated that the surgeon was not satisfied how the lens sat on the capsular bag.The incision was enlarged to remove the lens and suture were used.There was no patient injury.
Additional Manufacturer Narrative
Work order search: no similar complaints were reported for units within the same lot.(b)(4).

• Brand Name: SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY AG; hauptstrasse 104; ch-2560, nidau ; SZ
• MDR Report Key: 6373480
• Report Number: 2023826-2017-00275
• Device Sequence Number: 773218
• Product Code: HQL
• UDI-Device Identifier: 00841542100762
• UDI-Public: (01)00841542100762(17)191130
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2017

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: 11/30/2019
• Device Model Number: AA4203TL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/31/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2017
• Supplement Report FDA Received Date: 04/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MTC-60 CARTRIDGE LOT # UNK
• Outcome Attributed to Adverse Event: Required Intervention