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

Model Number	MICL12.6
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Iritis (1940); Patient Problem/Medical Problem (2688); No Code Available (3191)
Date of Event	03/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that he implanted a 12.6 mm micl12.6, -9.5 diopter, implantable collamer lens into the patient's right eye (od) on (b)(6) 2017.On (b)(6) 2018 the lens was explanted due to chronic iritis.It was reported that the patient was treated with durezol and pred forte for over three months.The reported stated that in his opinion the cause of event was due to patient sulcus anatomy.On (b)(6) 2018 the surgeon reported that the patient is continuing a steroid taper and that the patient continues to recover.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Device evaluation: the lens was returned dry, in a cartridge case.There was residue on product.Visual inspection found foreign material on lens surface (residue on lens) and the lens missing a piece of haptic.(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: 7448687
• Report Number: 2023826-2018-00586
• Device Sequence Number: 1216739
• Product Code: MTA
• UDI-Device Identifier: 00841542103015
• UDI-Public: 00841542103015
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2018

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: 07/31/2019
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 04/20/2018
• Supplement Report FDA Received Date: 06/04/2018
• 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