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

Model Number	MICL13.2
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Iritis (1940); Red Eye(s) (2038); No Code Available (3191)
Date of Event	07/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product is not marketed in the us.Device evaluation: product evaluation found that the lens was returned dry in the lens case/vial.Visual inspection found no visible damage to lens and red and clear residue on lens surface.(b)(4).Work order search: no similar complaints were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2 micl13.2, -7.5 diopter, implantable collamer lens in the patient's left eye (os) on (b)(6) 2017.The patient experienced recurring iritis, iris chaffing, and redness in eye.The lens was explanted on (b)(6) 2017.Addition of suture was also performed.The surgeon does not plan to implant another lens.The current condition of the patient is that she has vitreous bleed.The retina was evaluated and the surgeon believes it will make a full recovery.Therapy for iris repair and possible vitrectomy is planned.
Additional Manufacturer Narrative
Previous statement was incorrect.The product is marketed in the us.(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: 6786750
• Report Number: 2023826-2017-01193
• Device Sequence Number: 1771406
• Product Code: MTA
• UDI-Device Identifier: 00841542103244
• UDI-Public: 00841542103244
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2017

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
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/17/2017
• Supplement Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 08/22/2017
• 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: 32 YR