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

Model Number	VICM5 13.7
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	03/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6-investigation type 4110: lens work order search- no similar complaint event(s) within associated lots were found.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 13.7mm vicm5 13.7 implantable collamer lens of -9.50 diopter was implanted into the patients right eye (od) on (b)(6) 2024.Excessive vault and pain with headaches have been reported.The lens remains implanted.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional information: the reporter indicated that a 13.7mm vicm5 13.7 implantable collamer lens of -9.50 diopter was implanted into the patients right eye (od) on (b)(6) 2024.Excessive vault and pain with headaches have been reported.On (b)(6) 2024 the lens was explanted and on the same day a replacement lens of a shorter length was implanted.No update on the patients post op condition.If additional information is received a supplemental medwatch report will be submitted.Explant date: (b)(6) 2024.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information" b5- update given for patient 3 month post op exams as follows: on (b)(6) 2024: patient is ok / vault ok 580 / iop 21 - under treatment (diamox = acétazolamide).On (b)(6) 2024: peri orbital pain / vault ok / iop 32 - under treatment (diamox).On (b)(6) 2024: vault ok / iop 22 - under treatment (diamox).On (b)(6) 2024: vault ok / iop 25 - no treatment (no diamox).On (b)(6) 2024: peri orbital pain and nausea / vault ok / iop 34 - restart of treatment (diamox).On (b)(6) 2024: vault ok / iop 30 - under treatment (diamox).On (b)(6) 2024: slt / iop 22 - under treatment (diamox).On (b)(6) 2024: slt / iop 12 - under treatment (diamox).On (b)(6) 2024: iop 12.5 - no treatment (no diamox).On (b)(6) 2024: iop 13 - no treatment (no diamox).On (b)(6) 2024: no pain / iop 14 - no treatment (no diamox).Claim # (b)(4).
Additional Manufacturer Narrative
Additional data: h3 - device evaluation: the lens was returned dry in a microcentrifuge vial with residue/debris on the product.Visual inspection found the haptic deformed and stretched out.Dimensional inspection found the lens to be within specifications.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 muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 19177597
• Report Number: 2023826-2024-01865
• Device Sequence Number: 7231853
• Product Code: MTA
• UDI-Device Identifier: 00840311301256
• UDI-Public: 00840311301256
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/28/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: VICM5 13.7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2024
• Supplement Date Received by Manufacturer: 05/14/2024; 07/12/2024; 08/15/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 06/24/2024; 08/07/2024; 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2022
• 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: CARTRIDGE MODEL: SFC-45: LOT# 1592707; FOAM TIP PLUNGER (FTP), LOT# 1587623
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female