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

Model Number	VTICM5_12.6
Medical Device Problem Codes	Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	10/26/2023
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm vticm5_12.6; -4.00/+1.0/47 (sphere/cylinder/axis) implantable collamer lens into the patient's right eye (od) on (b)(6) 2023.The surgeon reports the patient had low vaulting; refractive surprise; and blurry vision.It was additionally noted that "consulting with ma what to do with the vault and refractive surprise".Lens remains implanted.The problem is not resolved.
Additional Manufacturer Narrative
B5: the reporter indicated that the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens of diopter -4.0/1.0/047 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6) 2023.The surgeon reports the patient had low vaulting, refractive surprise and blurry vision.The lens was exchanged on (b)(6) 2024 a same model and length lens.Reportedly the status of the eye is "vok-open, no cells, lens clear and centered".D6a: on (b)(6) 2023, d6b: on (b)(6) 2024, h6: 2199 corrected to 4629.Claim#: (b)(4).
Additional Manufacturer Narrative
D4: primary unique device identifier (udi) #: (b)(4).H4: device manufacture date: 30-jan-2023 corrected to 15-jan-2023.H3 - device evaluation: the lens was returned dry in a microcentrifuge vial.Visual inspection found no visible damage.Dimensional inspection found the lens to be within specifications.Functional inspection found that the returned lens did not meet original values measured at the time of manufacturing.H6 - type of investigation 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 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: 18125523
• Report Number: 2023826-2023-05096
• Device Sequence Number: 15391685
• Product Code: QCB
• UDI-Device Identifier: 00840311307708
• UDI-Public: (01)00840311307708(11)230115(17)251231
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2024

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: 12/31/2025
• Device Model Number: VTICM5_12.6
• 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: 10/30/2023
• Supplement Date Received by Manufacturer: 02/16/2024; 08/27/2024
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 03/04/2024; 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2023
• 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: INJECTOR MODEL-MSI-TF, LOT#-UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female