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

Model Number	MICL12.6
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	10/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the lens was returned in liquid inside a lens case/ vial.Visual inspection found tears in the haptic and a piece of haptic missing.Method code : no additional similar complaint type events were found within the associated lots.(b)(4).
Event or Problem Description
The reporter stated that the lens was torn during delivery on (b)(6) 2017.The surgeon stated that he believes the foam tip plunger (ftp) may not have expanded fully as the icl was advanced down the injector.As a result, the icl became partially stuck between the ftp and the injector and did not advance properly.The lens was placed into the eye but was torn at the trailing haptic/ footplate.The icl was then removed and a back-up lens was successfully implanted intraoperatively.Surgeon states that the whole process was completed in less than 30 minutes.
Additional Manufacturer Narrative
Corrected data: the reporter indicated that the implantable collamer lens, micl 12.6 of -13.0 diopter was torn during delivery on (b)(6) 2017.The surgeon stated that he believes the foam tip plunger (ftp) may not have expanded fully as the icl was advanced down the injector.As a result the icl became partially stuck between the ftp and the injector and did not advance properly.The lens was placed into the eye but was torn at the trailing haptic/ footplate.The icl was then removed and a back-up lens was successfully implanted intraoperatively.Surgeon states that the whole process was completed in less than 30 minutes.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: usage of device: "initial use of device" should have been checked in the initial mdr.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: 7048928
• Report Number: 2023826-2017-01778
• Device Sequence Number: 1450557
• Product Code: MTA
• UDI-Device Identifier: 00841542103084
• UDI-Public: 00841542103084
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/26/2017

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: 04/30/2019
• Device Model Number: MICL12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/21/2017
• Supplement Date Received by Manufacturer: 11/21/2017; 01/02/2018
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 11/21/2017; 01/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR