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 Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	11/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Lens work order search: no similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that a 13.2 mm micl13.2 lens, diopter -14.0 was to be explanted from the patient's left (os) eye on (b)(6) 2017, possibly due to an over vault.Attempts to obtain additional or updated information have been unsuccessful.
Additional Manufacturer Narrative
Corrected data: patient identifier - corrected from unk to ko.Date of birth: corrected to (b)(6).Implanted date: corrected to (b)(6) 2017.Explanted date: corrected from (b)(6) 2017 to not applicable.(b)(4).Claim# (b)(4).
Additional Manufacturer Narrative
The reporter indicated that the surgeon implanted a 13.2mm micl13.2 lens, -14 diopter, implantable collamer lens into the patient's left eye (os) on 11 nov 2017 due to "over vault".The symptoms of "over vault" were noted on (b)(6) 2017 and to date the lens remains implanted.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: 7109937
• Report Number: 2023826-2017-01882
• Device Sequence Number: 1068778
• Product Code: MTA
• UDI-Device Identifier: 00841542103374
• UDI-Public: 00841542103374
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 12/31/2018
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 02/08/2018; 02/27/2018
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 02/13/2018; 03/14/2018
• 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: 23 YR