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

Model Number	MICL12.6
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Iritis (1940); No Code Available (3191)
Date of Event	02/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient code:(b)(4) secondary surgical intervention,explant.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 he implanted a 12.6mm micl12.6, -8.5 diopter, implantable collamer lens in the patient's left eye (os) on (b)(6) 2018.On (b)(6) 2018 iritis was observed.The lens was explanted on (b)(6) 2018 due to persistent iritis and high iop (intraocular pressure).The surgeon reported to use combigan, durezol, pred forte, and lotemax over the course of treatment.It was reported that an iridectomy was performed.The surgeon reported that he believed the cause of the iritis was pigment dispersion from icl chafing of posterior iris.On (b)(6) 2018 the surgeon reported that he was not certain of why the inflammation continued.He stated that there were some pigmentary cells, but most were white cells and that the lens sizing was correct.He stated that the patient is doing well in soft contact lenses, inflammation is resolving.He also reported that they will be performing a proper fitting for the patient in the future.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Device evaluation: lens was returned dry, in a cartridge case.Lens was stuck to tape.Visual inspection found tape residue on lens.(b)(4).
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: 7404316
• Report Number: 2023826-2018-00506
• Device Sequence Number: 1963399
• Product Code: MTA
• UDI-Device Identifier: 00841542102995
• UDI-Public: 00841542102995
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: 07/31/2019
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 04/06/2018; 06/18/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 04/26/2018; 06/18/2018
• 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: 30 YR