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

Model Number	CC4204A
Medical Device Problem Codes	Positioning Failure (1158); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: collamer® ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Device evaluation: the product was returned in a biohazard bag.Visual inspection of the returned product found the lens returned in the cartridge.There was no visible damage to the cartridge or injector.Work order search: no similar complaints were reported for units within the same lot.Claim # (b)(4).
Event or Problem Description
The customer stated the surgeon was advancing a cc4204a collamer single piece lens, +20.0 diopter, in the cartridge and the plunger overrode and damaged the lens.There was no patient contact.The backup lens was implanted with no problem, using another nanopoint injector system.The reporter stated the lens damage was due to the nanopoint injector failed to perform.

• 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: 6679080
• Report Number: 2023826-2017-01097
• Device Sequence Number: 57501
• Product Code: HQL
• UDI-Device Identifier: 00841542102391
• UDI-Public: 00841542102391
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/09/2017

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: 11/30/2018
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2017
• Initial Report FDA Received Date: 06/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR