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 Code Available (3191)
Date of Event	12/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: product evaluation found that the lens was returned in liquid in a lens case/vial.Visual inspection found the haptic torn, the haptic detached from the lens, and an optic piece missing.(b)(4).Work order search: no similar complaints types events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted cq2015a, +19.0 diopter, in the patient's eye on (b)(6) 2017.The lens was explanted due to the haptic being tore.There was no patient injury.Attempts at obtaining addition information have been unsuccessful.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
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: 7183429
• Report Number: 2023826-2018-00041
• Device Sequence Number: 143155
• Product Code: HQL
• UDI-Device Identifier: 00841542101967
• UDI-Public: 00841542101967
• 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
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/15/2017

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?: 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: 01/04/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/15/2017
• Supplement Date Received by Manufacturer: 02/16/2018; 03/14/2018
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 02/16/2018; 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention