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 Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Device evaluation: lens was returned in liquid, in lens vial.Visual inspection found the optic in three pieces, multiple tears on the lens and pieces of the haptic missing.An injector and cartridge were returned with the lens.No visible damage to either device.Injector had tape on it.Work order search: no similar complaint were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter stated the surgeon inserted a cc4204a collamer single piece lens, +17.5 diopter, and the lens tore.The lens was removed with no patient injury.The backup lens was implanted with no problem.The reporter stated the cause of the event was unknown.

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6401558
• Report Number: 2023826-2017-00391
• Device Sequence Number: 737527
• Product Code: HQL
• UDI-Device Identifier: 00841542102346
• UDI-Public: (01)00841542102346(17)180430
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/15/2017

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: 04/30/2018
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2017
• Initial 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 SFC-25 LOT NUMBER UNK; INJECTOR MICROSTAAR INDIGO LOT NUMBER UNK
• Patient Age: 59 YR