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	Corneal Edema (1791); Intraocular Pressure Increased (1937); Pupillary Block (2026); Blurred Vision (2137); No Code Available (3191)
Date of Event	05/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Work order search: one similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 13.2mm micl13.2 implantable collamer lens, -12.5 diopter, in the patient's right eye (od) on (b)(6) 2017.The lens was explanted on (b)(6) 2017 due to excessive vaulting, elevated intraocular pressure, pupillary block, narrowing of the angle and shallowing of the anterior chamber.The patient experienced blurry vision and corneal edema.The reporter indicated multiple paracentisis performed and the peripheral iridectomies were redone.The patient was prescribed medication.The lens was not exchanged for another lens.The patients post-op condition is - trace k edema, 1+ cells with shallow anterior chamber, dilated pupil with corneal iris touch peripherally, and best-corrected visual acuity 20/200.The reporter indicated the cause of the event was unknown.
Additional Manufacturer Narrative
The reporter indicated the problem was not resolved after explantation of the lens.The patient continued to have intraocular pressure (iop) increase post explant of lens.At one week post-op, the patient underwent ahmed valve shunt insertion for iop, with glaucoma specialist.(b)(4).
Additional Manufacturer Narrative
Device evaluation: product evaluation found the lens returned in liquid in a specimen cup.Visual inspection found the haptic torn.(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: 6658366
• Report Number: 2023826-2017-00957
• Device Sequence Number: 1150382
• Product Code: MTA
• UDI-Device Identifier: 00841542103343
• UDI-Public: 00841542103343
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2017

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: 08/31/2018
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/25/2017
• Supplement Date Received by Manufacturer: Not provided; 06/23/2017
• Initial Report FDA Received Date: 06/21/2017
• Supplement Report FDA Received Date: 06/23/2017; 09/08/2017
• 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: 29 YR