MAUDE Adverse Event Report: STAAR SURGICAL COMPANY SEE H-10; INTRAOCULAR LENS

Model Number	CC4204A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	01/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Diopter: +20.00.Brand name: collamer® ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.(b)(4).Method: lens work order search.Results: a lens work order search revealed no similar complaint within the work order.A visual inspection of the returned product found one plate haptic has small tear.Lens was returned in liquid.Conclusions: conclusion not yet available.Evaluation is in progress.(b)(4).
Event or Problem Description
The reporter indicated the surgeon attempted to implanted a cc4204a +20.00 diopter collamer single piece lens in the patient's left eye.The capsule ruptured prior to inserting the nanoflex lens.The lens was inserted half way when the surgeon saw that it was not going to hold the lens, decided not to use it and removed the lens.The surgeon decided to implant a 3-piece lens.It was a small capsule tear and no vitectomy performed.The lens had nothing to do with the ruptured capsule.The patient's vision outcome is great.
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: 5461757
• Report Number: 2023826-2016-00202
• Device Sequence Number: 396437
• Product Code: HQL
• UDI-Device Identifier: 00841542102391
• UDI-Public: (01)00841542102391(17)171031
• 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): 01/27/2016

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: 10/31/2017
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/25/2016
• Supplement Report FDA Received Date: 05/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR