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

Model Number	MICL13.7
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was returned in liquid, in the lens vial.Visual inspection found cloudy residue on the lens.No similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that after opening the lens vial in order to implant a 13.7mm micl13.7 implantable collamer lens, -12.0 diopter, into the patient's right (od) eye, it was noticed that the lens was "cloudy." this occurred on (b)(6) 2019.There was no patient contact with this lens.The reporter states, "icl had opacification.".

• 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: 8350795
• Report Number: 2023826-2019-00278
• Device Sequence Number: 2253464
• Product Code: MTA
• UDI-Device Identifier: 00841542103602
• UDI-Public: 00841542103602
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/25/2019

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: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: MICL13.7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1