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

Model Number	MICL13.2
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Iritis (1940); Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Date of Event	02/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Work order search: no similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2 mm micl13.2, -12.5 diopter, implantable collamer lens into the patient's leftt eye (os) on (b)(6) 2018.On (b)(6) /2018 the lens was removed due to observation of excessive vault, elevated iop (intraocular pressure), significant reduction of irido-corneal angles, angle closure, pigment dispersion, unreactive (fixed) pupil, glare/haloes, and iris atrophy.Additional surgical intervention (enlargement, addition of new pi and repositioning) were performed.It was reported that at patients last follow up ((b)(6) 2018) the patient was on four different glaucoma drops, iop 25mmhg.Additional information reported, pi patent, patient reports decreased glare.Explanted icl after rotation, iris cell and flare increased the iop.
Additional Manufacturer Narrative
Device evaluation: the lens was returned in a therma scientific container.Visual inspection found the haptic torn and foreign material on lens surface (residue on lens).(b)(4).
Additional Manufacturer Narrative
Addition of new pi was not reported.
Additional Manufacturer Narrative
Additional information was received.The reporter stated that the patient had iritis due to the rubbing of the lens.The lens was rotated and the iritis still continued.Antibiotics and anti-inflammatories were used to address the inflammation.The problem of the cell and flare was resolved after the removal of the icl, there were no cell and flare post removal.(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: 7631046
• Report Number: 2023826-2018-00931
• Device Sequence Number: 2324194
• Product Code: MTA
• UDI-Device Identifier: 00841542103343
• UDI-Public: 00841542103343
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/25/2018

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: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 06/12/2018; 09/06/2018; 09/18/2018
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 08/16/2018; 09/06/2018; 09/25/2018
• 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: 28 YR