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 Codes	Capsular Bag Tear (2639); Vitrectomy (2643); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pt weight: - unk.Brand name: - collamer® ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Initial reporter: - unk.Event problem and evaluation codes: results code: the lens optic was torn in half.The lens was returned in liquid.Evaluation code: - based on the complaint history and the evaluation of the returned product, a specific root cause of the event could not be determined.(b)(4).
Event or Problem Description
A cc4204a, collamer single piece intraocular lens, +20.5 diopter was returned to the manufacturer torn in half.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
The reporter stated that the surgeon implanted a cc4204a intraocular lens and had to cut the lens to remove it due to a tear in the capsule.A vitrectomy was performed.No incision enlargement or sutures were required.The reporter stated the cause of the capsule tear is unknown and a staar phaco machine was not used.(b)(6).Work order search: no similar claims were reported for units with the same lot.Claim #(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: 6315880
• Report Number: 2023826-2017-00229
• Device Sequence Number: 968506
• Product Code: HQL
• UDI-Device Identifier: 00841542102407
• UDI-Public: (01)00841542102407(17)180531
• 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): 01/18/2017

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?: 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: 11/17/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/18/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2017
• Supplement Report FDA Received Date: 03/13/2017
• 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: CARTRIDGE MODEL AND LOT NUMBER - UNK; INJECTOR MODEL AND LOT NUMBER - UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR