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

Model Number MICL13.7

Device Problems Shelf Life Exceeded (1567); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Headache (1880); Intraocular Pressure Increased (1937); No Code Available (3191)

Event Date 07/18/2017

Event Type  Injury  

Manufacturer Narrative

Patient code: (b)(4) narrowing of the angle, shallowing of the acd, secondary surgery, lens exchange.(b)(4).

Event 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)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: michelle andres ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 6918173
• MDR Text Key: 88391028
• Report Number: 2023826-2017-01503
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103510
• UDI-Public: 00841542103510
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2017
• Initial Date FDA Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR