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

Model Number	MICL12.6
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unk.Investigation code (b)(6): lens work order search-no similar complaints reported for units within the same lot.Claim# (b)(64.
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, -9.5 diopter into the patient's eye.On (b)(6) 2022 the lens was removed due to excessive vault.Reportedly the lens was replaced.Attempts to obtain additional information have not been successful.
Additional Manufacturer Narrative
H3 - device evaluation: the lens was returned in liquid in an eye drop container.Visual inspection found no visible damage to the lens.Claim# (b)(4).
Additional Manufacturer Narrative
B5 - the reporter indicated that the surgeon implanted a 12.6mm micl12.6 implantable collamer lens of -9.5 diopter into the patient's left eye (os) on (b)(6) 2022.On (b)(6) 2022, the lens was explanted.On the same date in a separate surgery the lens was replaced with a shorter length lens due to excessive vault.The problem is resolved.Cause of event is unknown.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: 14254385
• Report Number: 2023826-2022-01386
• Device Sequence Number: 4846666
• Product Code: MTA
• UDI-Device Identifier: 00841542103015
• UDI-Public: 00841542103015
• 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: 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,Followup
• Report Date (Section B): 05/26/2022

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: 01/31/2024
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2022
• Supplement Date Received by Manufacturer: 05/26/2022; 05/26/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 06/06/2022; 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR
• Patient Sex: Female