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

Model Number	CC4204A
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4): collamer® ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.(b)(4).Method: evaluation method: lens work order search.Results: evaluation results: a lens work order search revealed one similar complaint within the work order.Visual inspection of the returned product found half of the lens, lengthwise is torn and missing.Half of both plate haptic and half of optic is torn off and missing.Lens cartridge was returned lens was returned in liquid.A mtc60c cartridge was returned stuck inside the vial.Unable to evaluate.Conclusions: (user error caused or contributed to event): based on the complaint information, it was determined that the root cause of this event was due to loading error.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a cc4204a +20.00 diopter collamer single piece lens in the patient's right eye.The lens tore on insertion.Lens was removed and backup lens, same model and size was implanted.There was no patient injury.A new scrub tech loaded the lens in wrong (mtc-60c fp) cartridge in error.
Additional Manufacturer Narrative
(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: 5448836
• Report Number: 2023826-2016-00110
• Device Sequence Number: 19075931
• Product Code: HQL
• UDI-Device Identifier: 00841542102391
• UDI-Public: (01)00841542102391(17)171031
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2016

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: 10/31/2017
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2016
• Supplement Report FDA Received Date: 05/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR