MAUDE Adverse Event Report: STAAR SURGICAL COMPANY SEE H10; INTRAOCULAR LENS (IOL)

Model Number	CC4204A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Collamer® ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Device evaluation: returned product evaluation found the lens with scratches on the optic.The lens was returned in liquid.Work order search: one similar claim was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter stated that the surgeon loaded a cc4204a, +27.5 diopter, single piece implantable collamer lens but switched to a aq2015a three piece silicone lens due to broken capsule prior to implantation.The reporter stated that it was not an issue with the lens.There was no vitrectomy and no sutures required.An evaluation of the returned product found scratches on the optic.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6361286
• Report Number: 2023826-2017-00264
• Device Sequence Number: 10991248
• Product Code: HQL
• UDI-Device Identifier: 00841542102544
• UDI-Public: (01)00841542102544(17)171130
• 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,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2017

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: 11/30/2017
• Device Model Number: CC4204A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/01/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2017
• Supplement Report FDA Received Date: 03/29/2017
• 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 AND LOT# - UNK; INJECTOR MODEL AND LOT# - UNK