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); Pain (1994); Pupillary Block (2026); Blurred Vision (2137); No Code Available (3191)
Date of Event	07/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that on (b)(6) 2017 the surgeon implanted a 13.2mm micl13.2 implantable collamer lens, diopter -14.5, into the patient's eye.It is planned to replace the lens with a shorter lens due to "a lot" of vaulting and pressure spike.Attempts to obtain further information have been unsuccessful.
Additional Manufacturer Narrative
Updated information: the lens was exchanged in the right (od) eye on (b)(6) 2017 for a shorter lens.After the lens exchange the iop decreased to 13 (previously spiked at 68).Additional symptoms include narrowing and angle closure, iridectomy, pain , blurred vision, yag revision, and pupil block.Device evaluation: lens was returned in liquid in the lens case/vial.Visual inspection found the haptic torn.(b)(4).
Additional Manufacturer Narrative
Additional information: the problem was resolved with the lens exchange.(b)(4).
Additional Manufacturer Narrative
Work order search: no similar complaint types were reported for units within the same lot.Corrected data: previous in mdr follow-up#1: the lens was exchanged in the right (od) eye on (b)(6) 2017 for a shorter lens.After the lens exchange the iop decreased to 13 (previously spiked at 68).Additional symptoms include narrowing and angle closure, iridectomy, pain , blurred vision, yag revision, and pupil block.Corrected: the lens was exchanged in the right (od) eye on (b)(6) 2017 for a shorter lens.After the lens exchange the iop decreased to 13 (previously spiked at 68).Additional symptoms include narrowing and angle closure, pain, blurred vision, and pupil block.Iridectomy was performed prior lens implant surgery and the surgeon also performed ac decompression and yag revision prior to explantation.(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: 6762432
• Report Number: 2023826-2017-01261
• Device Sequence Number: 1116436
• Product Code: MTA
• UDI-Device Identifier: 00841542103381
• UDI-Public: 00841542103381
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/11/2017

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: 12/31/2018
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/11/2017
• Supplement Date Received by Manufacturer: 08/01/2017; 08/28/2017; 09/21/2017
• Initial Report FDA Received Date: 08/02/2017
• Supplement Report FDA Received Date: 08/22/2017; 09/20/2017; 09/22/2017
• 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: 28 YR