MAUDE Adverse Event Report: STAAR SURGICAL COMPANY COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE IOL; INTRAOCULAR LENS

Model Number	CQ2015A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product evaluation found that the lens was returned dry and taped to the carteidge case.Visual inspection found the optic torn, the haptic torn, residue on the lens, lens torn in two pieces, and one of the haptics missing.One similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that when the surgeon attempted to implant a cq2015a, +19.0 diopter, intraocular lens in the patient's right eye (od) on (b)(6) 2017 the haptic of the lens wrapped around the injector.The lens was damaged and a back-up lens was implanted.No other information was provided.
Additional Manufacturer Narrative
Corrected data: the surgeon attempted to implant a cq2015a intraocular lens +19.0 diopter in the patient's right eye (od) on (b)(6) 2018 the haptic of the lens wrapped around the injector.Claim # (b)(4).

• Brand Name: COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 7398185
• Report Number: 2023826-2018-00495
• Device Sequence Number: 61520
• Product Code: HQL
• UDI-Device Identifier: 00841542101967
• UDI-Public: 00841542101967
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2018

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: 04/30/2019
• Device Model Number: CQ2015A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1