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

Model Number	MICL12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); No Code Available (3191)
Date of Event	07/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient code (b)(4): secondary surgical intervention, explant and additional suture (b)(4).
Event or Problem Description
The reporter indicated that tha 12.6mm micl12.6, -8.0 diopter, implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2018.On (b)(6) 2018 the lens was explanted with additional suture due to iris atrophy and pupil dilation.Additional information reported: chamber well framed.Iris atrophy at incision site.Pupil size normal.Superior corneal edema grade 2.Os visual field pass.Slight restriction inferior not in visual axis.Will follow up with visual field in 1 month.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Lens was returned in a contact lens container.Visual inspection found no visible damage to the lens.(b)(4).
Additional Manufacturer Narrative
Additional information: corneal edema resolved.Patient was treated with durezol 0.05% and zymaxid 0.5% as part of normal post-op regimen.(b)(4).Claim# (b)(4).
Additional Manufacturer Narrative
Additional information added: in the surgeon's opinion the cause of the event is a patient-related factor.Additional report sources added.(b)(4).Claim# (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: 7749218
• Report Number: 2023826-2018-01164
• Device Sequence Number: 19152461
• Product Code: MTA
• UDI-Device Identifier: 00841542102988
• UDI-Public: 00841542102988
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/06/2018

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: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Initial Date Received by Manufacturer: 07/06/2018
• Supplement Date Received by Manufacturer: 08/16/2018; 10/05/2018; 10/11/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 09/14/2018; 10/08/2018; 10/17/2018
• 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: 27 YR