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

Model Number	VICM5_13.2
Medical Device Problem Code	Misfocusing (1401)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	08/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Claim# (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2, -5.0 diopter implantable collamer lens into the patient's right eye (od) on (b)(6) 2023.It was reported that the patient has refractive surprise.The surgeon performed lri surgery.Lens remains implanted.It was reported that the cause of the event was reported as a user error with no device causality and noted "surgeon planned astigmatism correction with lri which doesn't work".If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
H1 - type of event - serious corrected to malfunction.H4 - manufacture date: 31-mar-2026 corrected to 05-april-2023.
Additional Manufacturer Narrative
B5 - reportedly in follow up email refractive treatment (lasik) was performed on an unknown date.This resolved the problem.D4 - unique identifier (udi) #: (b)(4).H1 - type of reportable event: serious to malfunction.H4 - device manufacture date: 05-apr-2023 corrected to 02-apr-2023.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 muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 17694988
• Report Number: 2023826-2023-03947
• Device Sequence Number: 6306437
• Product Code: MTA
• UDI-Device Identifier: 00840311300839
• UDI-Public: (01)00840311300839(11)230402(17)260331(21)S1898663
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2023

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: 03/31/2026
• Device Model Number: VICM5_13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 09/04/2023
• Supplement Date Received by Manufacturer: 11/21/2023; 10/25/2024
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 11/21/2023; 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2023
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female