MAUDE Adverse Event Report: STAAR SURGICAL COMPANY COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE IOL; 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)
Date of Event	03/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.(b)(4).
Event or Problem Description
The reporter indicated that as the cq2015a intraocular lens, diopter +22.0 was being injected into the patient's eye, the trailing haptic portion of the lens tore off.Reportedly, this was due to technician error.The lens was successfully exchanged intraoperatively with an alternate lens.This occurred on (b)(6) 2018.
Additional Manufacturer Narrative
Device evaluation: the lens was returned in liquid, in a lens vial.Visual inspection found the optic torn, haptic torn, and the haptic is separated from the lens.(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: 7438808
• Report Number: 2023826-2018-00559
• Device Sequence Number: 1591778
• Product Code: HQL
• UDI-Device Identifier: 00841542102025
• UDI-Public: 00841542102025
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2018

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: 07/31/2019
• Device Model Number: CQ2015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR