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

Model Number	VTICM5_13.2
Medical Device Problem Codes	Misfocusing (1401); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	04/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2; -6.00/+1.0/174 (sphere/cylinder/axis) implantable collamer lens into the patient's right eye (od).The patient experienced refractive surprise.Lens remains implanted.The cause of the event was reported as unknown.
Additional Manufacturer Narrative
H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: b5- the reporter indicated that the surgeon implanted a 13.2mm vticm5_ 13.2implantable collamer lens of diopter -6.0/+1.0/174 (sphere/cylinder/axis) into the patient's right eye (od) in (b)(6) 2023.The patient experienced refractive surprise.On (b)(6) 2024 the lens was explanted.On the same day separate surgery the lens was replaced with the same model, length lens and the problem was resolved.Status of the eye: "patient will be closely monitored" and "patient is happy".The reporter indicated the cause of the event is unknown.H6- health effect- impact code: "2199" should be removed and "4627" should be added.H6- medical device problem code: "2993" should be added.Device evaluation: h3 - type of investigation code: 10- device evaluation: the lens was returned in a microcentrifuge vial with moisture.Visual inspection found haptic bent.Dimensional inspection found the lens to be within specifications.Functional inspection found the returned lens did not meet original values measured at the time of manufacturing.Claim# (b)(4).
Additional Manufacturer Narrative
Additional data: 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 TORIC 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: 17039736
• Report Number: 2023826-2023-02153
• Device Sequence Number: 15051316
• Product Code: QCB
• UDI-Device Identifier: 00840311311101
• UDI-Public: 00840311311101
• 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 Explanted Year: 2024
• 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): 05/05/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Model Number: VTICM5_13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 05/05/2023
• Supplement Date Received by Manufacturer: 05/02/2024; 11/19/2024
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 10/22/2024; 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2022
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male