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

Model Number	MICL12.6
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Another similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, -9.5 diopter, in the patients right eye (od) on (b)(6) 2019.The lens was reported as having a low vault, but at 3 days post-operative, the vault had improved and the patient was being monitored.The patient had no complaints and was doing very well.The lens remains implanted.

• 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: 8356308
• Report Number: 2023826-2019-00282
• Device Sequence Number: 2127301
• Product Code: MTA
• UDI-Device Identifier: 00841542103015
• UDI-Public: 00841542103015
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2019

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: 05/31/2020
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 02/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR