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

Model Number	CC4204A
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Vitrectomy (2643)
Date of Event	04/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Brand name: collamer® ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a cc4204a +21.00 diopter collamer single piece lens in the patient's left eye.The lens tore on insertion into the eye.There was a capsule tear and a vitrectomy was performed.The lens was removed and a 3-piece staar lens was implanted.Cause of lens tear and capsule tear is unknown.
Additional Manufacturer Narrative
Event problem and evaluation codes: result code(s): (operational problem) : visual inspection of the returned product found the lens torn into two pieces, from one haptic through the optic to the other haptic.There was a piece missing.The lens was returned in liquid.(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: 5661777
• Report Number: 2023826-2016-00608
• Device Sequence Number: 250133
• Product Code: HQL
• UDI-Device Identifier: 00841542102414
• UDI-Public: (01)00841542102414(17)180228
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/20/2016

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: 02/28/2018
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2016
• Supplement Report FDA Received Date: 10/04/2016
• 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: 66 YR