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); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age or date of birth: unk.Weight: unk.Race: unk.(b)(4).Device evaluation: lens was returned in a specimen cup with moisture.Visual inspection found no visible damage to the lens.Claim # (b)(4).
Event or Problem Description
It was reported that a 13.2mm, micl13.2, -8.5 diopter, implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2021.On (b)(6) 2021 the lens was exchanged for a shorter length lens due to excessive vault (1.42mm vault), mild dilated pupil and elevated iop (requiring drops).This exchange resolved the problem.Device, patient- related factor, unknown, icl too large was reported for cause of this event.For status of the eye (signs/symptoms) the reporter stated " improved-comfortable".

• 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: 11721772
• Report Number: 2023826-2021-01127
• Device Sequence Number: 3308861
• Product Code: MTA
• UDI-Device Identifier: 00841542103268
• UDI-Public: 00841542103268
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2021

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: 07/31/2022
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 04/24/2021
• 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