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

Model Number	CC4204A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pt age and weight: unk.Concomitant medical product(s): collamer® ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Implant and explant dates: unk.Initial reporter: unk.Device evaluation: visual inspection of the returned product found no visible damage to the lens.The lens was returned in liquid.Work order search: no similar complaints were reported for units within the same lot.(b)(4).
Event or Problem Description
A cc4204a collamer single piece lens, +24.0 diopter was returned to the manufacturer with no damage.The facility reported complications on (b)(6) 2016 and the doctor changed to a three piece lens.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: 6412056
• Report Number: 2023826-2017-00417
• Device Sequence Number: 19016832
• Product Code: HQL
• UDI-Device Identifier: 00841542102476
• UDI-Public: (01)00841542102476(17)171231
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 12/31/2017
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2017
• Initial Report FDA Received Date: 03/16/2017
• 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 NUMBER UNK; INJECTOR MODEL AND LOT NUMBER UNK
• Outcome Attributed to Adverse Event: Required Intervention