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

Model Number	CC4204A
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device 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.Once the lens was implanted, the physician noticed it was too tight.The lens was too big.The lens was cut into pieces to remove from eye.The physician decided to implant a cq2015a lens.No patient injury.Cause of this incident is unknown.The reporter was asked if the cause was due to mis-measurement or due to patient anatomy and they said no, it was just not a right fit.

• 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: 5648957
• Report Number: 2023826-2016-00607
• Device Sequence Number: 10901219
• 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
• Report Date (Section B): 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2016
• Initial Report FDA Received Date: 05/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 66 YR