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

Model Number	MICL13.7
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 13.7mm micl13.7 implantable collamer lens, -16.0 diopter, in the patients left eye (os) on (b)(6) 2018.The lens was explanted on (b)(6) 2018 due to excessive vaulting and pupil/icl touch, with ovoid pupil.The lens was exchanged for a shorter lens and the problem was resolved.
Additional Manufacturer Narrative
Additional data: device evaluation: lens was returned in liquid in a lens vial.Visual inspection found a tear in the haptic.(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: 7987402
• Report Number: 2023826-2018-01535
• Device Sequence Number: 1747015
• Product Code: MTA
• UDI-Device Identifier: 00841542103688
• UDI-Public: 00841542103688
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2018

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: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: MICL13.7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 11/16/2018
• 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
• Patient Age: 25 YR