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

Model Number	MICL13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Inflammation (1932); Intraocular Pressure Increased (1937); Iritis (1940); Uveitis (2122); No Code Available (3191)
Date of Event	06/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: lens was returned in liquid, in a small plastic container.Visual inspection found a haptic tear.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 13.2mm micl13.2, -13.5 diopter, implantable collamer lens into the patient's right eye (od) on (b)(6) 2018.On (b)(6) 2018 the lens was explanted due to observation of excessive vault, elevated iop (intraocular pressure) without pupil block and angle closure, iris atrophy, increased cell, and flare/inflammation.Patient was on antibiotics and anti-inflammatories to address the inflammation.It was reported that at patients last follow up there was no pain, no ache, decreased inflammation and patient is doing well.
Additional Manufacturer Narrative
No similar complaint type events were reported for units within the same lot.(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: 7714154
• Report Number: 2023826-2018-01016
• Device Sequence Number: 13702110
• Product Code: MTA
• UDI-Device Identifier: 00841542103367
• UDI-Public: 00841542103367
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2018

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: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 09/18/2018; 09/19/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 09/18/2018; 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE: SFC-45 W/FOAM TIP PLUNGERLOT# UNK; INJECTOR MODEL: MSI-TF, LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR