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	Intraocular Pressure Increased (1937); Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Date of Event	04/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: lens was returned in liquid, in a specimen cup.Visual inspection found no visible damage to the lens.(b)(4).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 a 13.2mm micl13.2, -12.50, implantable collamer lens was implanted 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 intraocular pressure without pupil block and angle closure (date assessed: (b)(6) 2018), unreactive (fixed) pupil, glare/haloes, and blurred vision.Additional surgical intervention ( enlargement of pi; yag) and medical intervention (intraocular injection) were performed/prescribed.The reported stated that the cause of this event was unknown."fixed pupil" was reported for status of the eye at patient's last follow up.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional information received: as of (b)(6) 2018 best corrected acuity 20/30, iop is elevated to 27um.Patient is being monitored for ocular hypertension.Corrections: patient did not have intraocular injections.(b)(4).
Additional Manufacturer Narrative
Device evaluation: lens was returned in liquid lens case/vial.Visual inspection found no visible damage to lens.Dimensional inspection found the lens within specifications.Corrected data: (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: 7480272
• Report Number: 2023826-2018-00657
• Device Sequence Number: 16570223
• Product Code: MTA
• UDI-Device Identifier: 00841542103343
• UDI-Public: 00841542103343
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Report Date (Section B): 04/04/2018

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: 04/18/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/04/2018
• Supplement Date Received by Manufacturer: 05/08/2018; 08/09/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 06/05/2018; 08/10/2018
• 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: 37 YR