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

Model Number	MICL12.6
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Inflammation (1932); Intraocular Pressure Increased (1937); Uveitis (2122); No Code Available (3191)
Date of Event	05/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, -12.0 diopter, in the patients right eye (od) on (b)(6) 2019.The lens was explanted on (b)(6) 2019 due to excessive vaulting, pigment dispersion and anterior chamber inflammation.The reporter indicated the excessive vaulting caused pigment dispersion (increasing intraocular pressure controlled on drops and heavy pigment on icl), and anterior chamber inflammation spikes as steroids were tapered.The patient had constant aching sensation but the patient is doing well at one-day post-op explant exam.The cause of the event was due to the device.
Additional Manufacturer Narrative
Dave of event: corrected to (b)(6) 2019 in initial mdr.Claim#: (b)(4).
Additional Manufacturer Narrative
Device evaluation: the lens was returned in liquid in a specimen cup.Visual inspection found the haptic torn.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: 8742046
• Report Number: 2023826-2019-01154
• Device Sequence Number: 1489857
• Product Code: MTA
• UDI-Device Identifier: 00841542103060
• UDI-Public: 00841542103060
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/30/2019

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: 07/31/2019
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 08/21/2019; 09/09/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 08/21/2019; 09/10/2019
• 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: 44 YR