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

Model Number	MICL 13.7
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); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Reportedly a 13.7mm micl13.7 implantable collamer lens of -3.5 diopter was removed due to high vault.It was replaced with a shorter length lens on (b)(6) 2022.The lens was removed on (b)(6) 2022.
Additional Manufacturer Narrative
Patient identifier: unknown,age or date of birth:unknown, sex::unknown, weight: unknown, ethnicity:unknown, race:unknown.Date of event: unk.Claim# (b)(4).
Additional Manufacturer Narrative
B5 - the reporter indicated that a 13.7mm micl13.7 implantable collamer lens of -3.5 diopter was implanted into the patient's left eye (os) on (b)(6) 2022.Reportedly excessive vault, elevated iop, and narrow angles were found.The lens was explanted on (b)(6) 2022, and replaced on the same day in a separate surgery with a shorter length lens of a different model.This resolved the problem.H6- health effect- clinical code 4581: narrow angles.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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 14382243
• Report Number: 2023826-2022-01508
• Device Sequence Number: 20121137
• Product Code: MTA
• UDI-Device Identifier: 00841542103435
• UDI-Public: 00841542103435
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 05/06/2022

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: 06/30/2022
• Device Model Number: MICL 13.7
• 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: 04/13/2022
• Supplement Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 06/20/2022
• Date Device Manufactured: 07/30/2020
• 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: CARTRIDGE MODEL-SFC-45, LOT#-UNK.; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK.; INJECTOR MODEL-MSI-PF, LOT#-UNK.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female