MAUDE Adverse Event Report: STAAR SURGICAL COMPANY SEE H-10; 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	11/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Collamer® ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.(b)(4).
Event or Problem Description
The reporter indicated the surgeon attempted to insert a cc4204a collamer single piece lens, +17.5 diopter, and noted, under the microscope, the lens was damaged.The lens touched the patient's eye and was not inserted.There was no patient injury.The backup lens was implanted with no problem.
Additional Manufacturer Narrative
Result code: visual inspection of the returned product found the lens cut in two pieces, the optic and haptic torn and piece of the haptic missing.Lens was returned in minimal amount of liquid.The nanopoint injector system was returned with no visible damage to device.There was dry clear residue on the device and a pieced lens stuck in the cartridge.Conclusion code: - based on the complaint history, work order search and the evaluation of the returned product, a specific root cause of the event could not be determined.Claim #(b)(4).
Additional Manufacturer Narrative
H4: 09/01/2016 to 09/16/2016.No similar claims were reported for units within the same lot.(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: 6251940
• Report Number: 2023826-2017-00056
• Device Sequence Number: 10951545
• Product Code: HQL
• UDI-Device Identifier: 00841542102346
• UDI-Public: (01)00841542102346(17)180831
• 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
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 08/31/2018
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/14/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/13/2017
• Supplement Report FDA Received Date: 02/07/2017; 03/15/2017
• 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