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

Model Number	CQ2015A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pt info: unk.Event date: unk.Collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens.Implant and explant dates: unk.Initial reporter: unk.(b)(4).
Event or Problem Description
The reporter indicated that a cq2015a intraocular lens, diopter +13.0 was "implanted and removed.No injury to patient, no more information." reportedly, lens was explanted because the surgeon "didn't like how it look." attempts to obtain additional information have not been successful.
Additional Manufacturer Narrative
Additional information: lens was implanted on (b)(6) 2018 into the patient's right (od) eye.The lens was returned in liquid, in a lens vial.Visual inspection found the haptic bent.(b)(4).
Additional Manufacturer Narrative
Work order search: no similar complaint types were reported for units within the same lot.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: 8127059
• Report Number: 2023826-2018-01772
• Device Sequence Number: 16725625
• Product Code: HQL
• UDI-Device Identifier: 00841542101844
• UDI-Public: 00841542101844
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2018

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: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: CQ2015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 12/05/2018; 02/12/2019
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 01/02/2019; 02/13/2019
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention