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

Model Number	CC4202A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Visual inspection of the returned product found the lens optic scratched.The lens was returned in liquid.(b)(4).
Event or Problem Description
The reporter stated that a (b)(4), +24.5 diopter, lens was opened on a sterile field and the surgeon decided to go with a different power.The reporter stated there was no patient contact and she did not know the cause of the damaged lens.
Additional Manufacturer Narrative
Corrected data: cc4202a to cc4204a - incorrect model # reported.(b)(4).

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6362802
• Report Number: 2023826-2017-00278
• Device Sequence Number: 19018742
• Product Code: HQL
• UDI-Device Identifier: 00841542102483
• UDI-Public: (01)00841542102483(17)171130
• 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,Followup
• Report Date (Section B): 01/31/2017

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: CC4202A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/31/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2017
• Supplement Report FDA Received Date: 04/10/2017
• 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
• Patient Age: 69 YR