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

Model Number	MICL13.7
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lens was returned in liquid in the lens vial.Visual inspection found a tear in the optic.No similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
Reportedly, while preparing to insert a 13.7mm micl13.7, diopter -8.5 implantable collamer lens into the patient's right (od) eye, the lens tore.This occurred during the loading process.Reporter states that the surgeon noticed "a lot of bubbles" and when trying to pull the lens through "she had to grab [the lens] a couple of times." there was no patient contact with this lens.This occurred on (b)(6) 2017.

• Brand Name: IMPLANTABLE COLLAMER LENS
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 7006993
• Report Number: 2023826-2017-01691
• Device Sequence Number: 1601306
• Product Code: MTA
• UDI-Device Identifier: 00841542103534
• UDI-Public: 00841542103534
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/13/2017

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: 09/30/2018
• Device Model Number: MICL13.7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 11/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR