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

Model Number	MICL13.7
Medical Device Problem Codes	Shelf Life Exceeded (1567); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Headache (1880); Intraocular Pressure Increased (1937); No Code Available (3191)
Date of Event	07/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient code: (b)(4) narrowing of the angle, shallowing of the acd, secondary surgery, lens exchange.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a micl13.7, -7.5 diopter, implantable collamer lens in the patient's left eye (os) on (b)(6) 2017.On (b)(6) 2017, the lens was explanted due to intermittent elevated iop, headaches, excessive vaulting, narrowing of the angle, and shallowing of the acd.The lens was exchanged with a new lens.

• 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: 6918173
• Report Number: 2023826-2017-01503
• Device Sequence Number: 19184584
• Product Code: MTA
• UDI-Device Identifier: 00841542103510
• UDI-Public: 00841542103510
• 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
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 12/31/2016
• Device Model Number: MICL13.7
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 10/05/2017
• 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: 44 YR