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

Model Number	CC4204A
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brand name: collamer® ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.(b)(4).
Event or Problem Description
The reporter indicated a cc4204a collamer single piece lens, +23.5 diopter, was damaged by the injector during the loading process.There was no patient contact and the backup lens was implanted.The reporter indicated a possible cause of the event was the nanopoint injector system.
Additional Manufacturer Narrative
Device evaluated by manufacturer?: visual inspection of the returned product found no visible damage to the lens.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: 6251938
• Report Number: 2023826-2017-00057
• Device Sequence Number: 13691773
• Product Code: HQL
• UDI-Device Identifier: 00841542102469
• UDI-Public: (01)00841542102469(17)180228
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2016

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: 02/09/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2017
• Supplement Report FDA Received Date: 02/17/2017
• 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 NANOPOINT - LOT NUMBER UNK; INJECTOR MODEL NANOPOINT - LOT NUMBER UNK
• Patient Age: 80 YR