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

Model Number	MICL13.2
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No similar complaints types events were reported for units within the same lot.Lens was returned in liquid, in lens vial.Visual inspection found no visible damage to the lens.(b)(4).
Event or Problem Description
The reporter indicated that during loading of a micl13.2, -15.0 diopter, implantable collamer lens, it was noted that a portion of one of the footplates was missing.There was no patient contact.
Additional Manufacturer Narrative
Corrected data: expiration date: it is corrected from "31-jan-2018" to "31-jan-2019".Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: device evaluation: lens was returned in liquid inside a lens vial.Visual inspection found the lens missing a piece of its haptic.Claim# (b)(4).

• Brand Name: MICL
• Common Device Name: IMPLANTABLE COLLAMER LENS (ICL)
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 7294025
• Report Number: 2023826-2018-00266
• Device Sequence Number: 1342904
• Product Code: MTA
• UDI-Device Identifier: 00841542103398
• UDI-Public: 00841542103398
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2018

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: 01/31/2019
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 04/06/2018; 04/20/2018
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 04/06/2018; 04/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1