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	No Code Available (3191)
Date of Event	01/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 there were no similar complaints within the work order.Visual inspection of the returned product found the lens in two pieces.Unable to evaluate.Lens was returned dry.Conclusions: based on the complaint history, work order search and the returned product, the root cause of the event has been determined to be due to patient's anatomy and was not lens related.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a cc4204a +16.00 diopter collamer single piece lens in the patient's right eye.The patient's iris was floppy and the lens would not sit well in the eye.The lens was cut in little pieces to remove from the eye.The incision was not enlarged, a sulcus lens was implanted and no suture was needed.No issues with the lens itself.This incident was due to patient anatomy.This the first of two lenses used on the same patient, same eye.See mfr.Report # 2023826-2016-00176 for other lens.
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: 5496581
• Report Number: 2023826-2016-00175
• Device Sequence Number: 19123083
• Product Code: HQL
• UDI-Device Identifier: 00841542102315
• UDI-Public: (01)00841542102315(17)171130
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2016

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: 12/02/2015
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2015
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2016
• Supplement Report FDA Received Date: 05/06/2016
• 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: 49 YR