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

Model Number	CQ2015A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens.(b)(4).
Event or Problem Description
The reporter indicated the surgeon inserted a cq2015a collamer three piece lens, +21.0 diopter, and the haptic bent.The lens was removed with no patient injury.Another same model lens was implanted.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Corrected data: (b)(4).
Additional Manufacturer Narrative
The reporter stated the lens was inserted and removed during the same surgery, with no patient injury, no enlarged incision or sutures.The cause of the event was unknown.Device evaluation: the lens was returned in liquid in a case/vial.Visual inspection of the returned product found the lens torn into two pieces.One haptic was bent.Claim # (b)(4).

• 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: 6919972
• Report Number: 2023826-2017-01539
• Device Sequence Number: 19012094
• Product Code: HQL
• UDI-Device Identifier: 00841542102001
• UDI-Public: 00841542102001
• 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
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2017

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: 02/28/2018
• Device Model Number: CQ2015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/25/2017
• Supplement Date Received by Manufacturer: 10/09/2017; 12/01/2017
• Initial Report FDA Received Date: 10/06/2017
• Supplement Report FDA Received Date: 10/19/2017; 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1