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

Model Number	CQ2015A
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Device evaluation: lens was returned in liquid in the lens vial.Visual inspection found the optic torn in two pieces.Work order search: no similar complaint types reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that as the surgeon was attempting to load a 13.0mm cq2015a implantable collamer lens diopter +15.0, the surgeon had a problem loading the lens.The reporter stated no patient injury.Upon lens return, the box had the words "patient contact" written on it.Attempts to obtain additional information have been unsuccessful.
Additional Manufacturer Narrative
Additional information received from reporter: the surgeon attempted to insert the lens and noted the lens was torn.The lens touched the patient's eye but was not inserted.The back-up lens was implanted.A non-staar injection system was used.Reportedly, the technician had a problem loading the lens and the cause of the event was user error.No additional information provided.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: 6832599
• Report Number: 2023826-2017-01388
• Device Sequence Number: 18843347
• Product Code: HQL
• UDI-Device Identifier: 00841542101882
• UDI-Public: 00841542101882
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2017

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: 08/31/2018
• Device Model Number: CQ2015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/08/2017
• Supplement Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1