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

Model Number	CC4204A
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brand name: collamer® ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Visual inspection of the returned product found the lens stuck inside the cartridge.There was no visible damage to the cartridge.(b)(4).
Event or Problem Description
The cc4204a collamer single piece lens +21.0 diopter was returned to the manufacturer stuck inside the nanopoint cartridge.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.

• 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: 5806559
• Report Number: 2023826-2016-00959
• Device Sequence Number: 10813262
• Product Code: HQL
• UDI-Device Identifier: 00841542102414
• UDI-Public: (01)00841542102414(17)171130
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/20/2016

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: 11/30/2017
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2016
• Initial Report FDA Received Date: 07/19/2016
• 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: INJECTOR MODEL - NANOPOINT - LOT NUMBER UNK
• Patient Age: 79 YR