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	Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product is marketed in the u.S.(b)(4).Work order search: no similar complaints were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon was attempting to implant a cq2015a intraocular lens in the patient's left eye (os) but the haptic broke while being inserted due to the lens being loaded incorrectly.Pars plana vitrectomy was performed on the patient.During the surgery, part of the iris ripped when lens had to be removed from eye.
Additional Manufacturer Narrative
(b)(4).Conclusion: previous code is not applicable, this lens model is contraindicated for patients under 60 years of age.(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: 6773528
• Report Number: 2023826-2017-01290
• Device Sequence Number: 1568607
• Product Code: HQL
• UDI-Device Identifier: 00841542102001
• UDI-Public: 00841542102001
• 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
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 10/31/2018
• 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: 04/08/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/11/2017
• Supplement Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 08/08/2017
• Supplement Report FDA Received Date: 09/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR
• Patient Weight: 98