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

Model Number	VICM5_ 12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6- type of investigation code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.H11- secondary surgical intervention to remove/replace/reposition the lens is identified in the labeling as a known potential adverse event following icl implantation.Claim (b)(4).
Event or Problem Description
A healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced cloudiness".In a separate visit the lens was explanted.Reportedly, "patient elected to not replace".If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional data: b5 a healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced "cloudiness".In a separate visit the lens was explanted.Reportedly, "patient elected to not replace".The cause of the event was reported as the device.Cause details provided: "device was reported defective due to clouding.Clouding became worse".(b)(4).
Additional Manufacturer Narrative
Corrected data: b5- a healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, "the lens clouded and needed to be removed".Reportedly, "implanted a lens that stars issued a voluntary recall notice for.At the time, the patient was seeing well and there was not an issue, discovered a 'cloudiness' to this icl that was implanted".In a separate visit the lens was explanted.Reportedly, "after problem with icl patient preferred no icl and instead clear lens exchange.I provided this surgery for free due to failure of the device.Now patient now sees better than 20/20".The cause of the event was reported as the device.Cause details provided: "device was reported defective due to clouding.Clouding became worse".H6-health effect- clinical code: "4581- clear lens exchange" and "lens clouded" should be added.Additional information: h6- type of investigation code: 3331- device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.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: 20754236
• Report Number: 2023826-2024-05328
• Device Sequence Number: 21148084
• Product Code: MTA
• UDI-Device Identifier: 00841542119191
• UDI-Public: (01)00841542119191(11)221110(17)241031
• 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: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/13/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: VICM5_ 12.6
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: 11/21/2024; 01/08/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 12/03/2024; 02/18/2025
• Date Device Manufactured: 11/10/2022
• 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#-UNK.; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK.; INJECTOR MODEL-MSI-PF, LOT#-UNK.; INJECTOR MODEL: LIOLI-24, LOT# FCK2505.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female