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

Model Number	MICL13.2
Medical Device Problem Codes	Misfocusing (1401); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight: unk.Ethnicity: unk.Race: unk.Date of event: unk.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 13.2mm micl13.2 implantable collamer lens, -14.00 diopter, in the patients right eye (od) on (b)(6) 2022.The lens was explanted on (b)(6) 2022 due to refractive error.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
B5: the lens was explanted due to a refractive surprise.The lens was replaced with another same model/length but different diopter (-12.5) lens and the problem was resolved.Patient is doing well.H6 - device code: 1494 - this lens model is contraindicated for patients with a pre-existing condition - blepharitis.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
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 14215070
• Report Number: 2023826-2022-01336
• Device Sequence Number: 12072991
• Product Code: MTA
• UDI-Device Identifier: 00841542103374
• UDI-Public: 00841542103374
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2022

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: 03/31/2023
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Sex: Male