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	Intraocular Pressure Increased (1937); No Code Available (3191)
Date of Event	07/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter stated the surgeon implanted a 13.2mm micl13.2 implantable collamer lens, -12.5 diopter.In the patient's left eye (os) on (b)(6) 2017.The lens had a high vault and due to concerns over angle closure, the lens was explanted on (b)(6) 2017.The patient experienced elevated intraocular pressure and narrowing of the angle.The lens was exchanged for a shorter lens and the problem was resolved.The patient's current condition was 20/20 ucva, with great intraocular pressure.The reporter stated the cause of the event was unknown.
Additional Manufacturer Narrative
Device evaluation: the lens was returned in liquid in a vial.Visual inspection of the returned product found a piece of one haptic torn off and missing.(b)(4).
Additional Manufacturer Narrative
The lens was exchanged for a shorter lens and upon implantation there was a residual vaulting.The surgeon enlarged pi and resolved the problem.(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: 6767795
• Report Number: 2023826-2017-01250
• Device Sequence Number: 1947668
• Product Code: MTA
• UDI-Device Identifier: 00841542103343
• UDI-Public: 00841542103343
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2017

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: 11/30/2018
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/14/2017
• Supplement Date Received by Manufacturer: 08/11/2017; 10/13/2017
• Initial Report FDA Received Date: 08/04/2017
• Supplement Report FDA Received Date: 09/07/2017; 10/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL SFC-45 FP - LOT NUMBER UNK; FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK; INJECTOR MODEL MSI-PF - LOT NUMBER UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR