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

Model Number	MICL13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	02/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: lens was returned in liquid, in lens vial.Visual inspection found a haptic tear.(b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm micl13.2, -11.5 diopter, implantable collamer lens was explanted and exchanged for a shorter length lens.It was reported that there was no patient injury.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
The reporter indicated that the surgeon implanted a 13.2mm micl13.2 implantable collamer lens of -11.5 diopter in the patient's right eye (od) on (b)(6) 2018.The lens was exchanged for a shorter lens on (b)(6) 2018.It was reported that there was no patient injury.The patient's post-op ucva was reported to be 20/15.(b)(4).
Additional Manufacturer Narrative
Implanted date: it is corrected from "(b)(6) 2018" to "(b)(6) 2018".Explanted date: it is corrected from "unk" to "(b)(6) 2018".(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: 7448874
• Report Number: 2023826-2018-00585
• Device Sequence Number: 2053653
• Product Code: MTA
• UDI-Device Identifier: 00841542103329
• UDI-Public: 00841542103329
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/21/2018

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: Physician
• Device Expiration Date: 09/30/2019
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 06/06/2018; 06/25/2018
• Initial Report FDA Received Date: 04/20/2018
• Supplement Report FDA Received Date: 06/21/2018; 06/26/2018
• 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: 33 YR