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

Model Number	CQ2015A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lens was returned in liquid, in a lens case/vial.Visual inspection found no visible damage to the lens.No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that during implantation of a cq2015a , +20.5 diopter, collamer lens, the cartridge split open and the lens started coming out from the side of the cartridge.There was no patient injury and the back up lens was implanted with no issues.The reporter stated that the cause of event was due to a loading issue.
Additional Manufacturer Narrative
Corrected information: lens was never implanted: date is n/a.Lens was never implanted: date is n/a.Claim# (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: 7291078
• Report Number: 2023826-2018-00263
• Device Sequence Number: 11019974
• Product Code: HQL
• UDI-Device Identifier: 00841542101998
• UDI-Public: 00841542101998
• 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
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2018

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: 05/31/2019
• Device Model Number: CQ2015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 05/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR