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

Model Number	MICL13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Headache (1880); Intraocular Pressure Increased (1937); Blurred Vision (2137); No Code Available (3191)
Date of Event	03/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient code: secondary surgical intervention, explant.Narrowing of the angle, angle closure, shallowing of the acd.Work order search: no similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The surgeon indicated that a 13.2mm micl13.2, -7.0 diopter, implantable collamer lens was implanted in the patient's right eye (od) on (b)(6) 2018.Patient reported to have blurry vision and headache.On (b)(6) 2018 the surgeon observed excessive vault, elevated iop (intraocular pressure), narrowing of the angle, angle closure and shallowing of the acd (anterior chamber depth).Patient was put on glaucoma medication and an anterior chamber wash out was performed.The lens was explanted on (b)(6) 2018.Glaucoma drops were given and iop (intraocular pressure) returned to normal.Surgeon reported that the cause of event is unknown- combination of trauma (patient accidently hit her eye with hand on (b)(6) 2018), lens length, small 2nd lpi (laser peripheral iridotomy).
Additional Manufacturer Narrative
(b)(4).

• 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: 7404820
• Report Number: 2023826-2018-00508
• Device Sequence Number: 19002675
• Product Code: MTA
• UDI-Device Identifier: 00841542103237
• UDI-Public: 00841542103237
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2018

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: 12/31/2018
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 06/05/2018
• 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: 29 YR