MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC INTRAOCULAR LENS

Model Number	CQ2015A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that a cq2015a collamer three piece lens,+21.5 diopter, was implanted and removed within the same surgery because the surgeon noticed a pigment on the lens and the lens looked thicker than normal.The reporter stated that the or technician inspected the lens prior to loading but did not notice anything unusual with the lens.There was no patient injury and the backup lens was implanted.
Additional Manufacturer Narrative
Corrected data: should have been in initial mdr.Injector model: msi-pm and cartridge model: cq.Claim # (b)(4).
Additional Manufacturer Narrative
Device evaluation: lens was returned in liquid, in lens case/vial.Visual inspection found the lens torn in two pieces, hapitcs separated from lens and a tear in the optic.Claim #: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 7155973
• Report Number: 2023826-2017-01985
• Device Sequence Number: 16638878
• Product Code: MTA
• UDI-Device Identifier: 00841542102018
• UDI-Public: 00841542102018
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/29/2017

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: 05/31/2019
• Device Model Number: CQ2015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 01/10/2018; 02/16/2018
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 01/19/2018; 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR