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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2: unk, a4: unk, a5: unk, a6: unk, b3: unk, d4: expiration date unk, d6a: unk, d6b: unk, h4: unk.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens, -13.50/+1.0/002 (sphere/cylinder/axis), in the patients left eye (os).The patient experienced a refractive surprise and the lens remained implanted.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
H6 - work order search: no similar complaint was reported for units within the same lot.B5: the reporter indicated the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens, -13.50/+1.0/002 (sphere/cylinder/axis), into the patients left eye (os) on (b)(6)2023.The lens was reported as low vaulting and patient experienced a refractive surprise.The lens remained implanted.The cause of the event was due to the device.Additional information has been requested but none has been forthcoming.Claim # (b)(4).
Additional Manufacturer Narrative
B5 - surgeon contacted advising "that he did lasik and patient is 6/6 after the lasik procedure".Also reported "os lens remains implanted".Claim # (b)(4).
Additional Manufacturer Narrative
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.(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 ; 6263037902
• MDR Report Key: 18249826
• Report Number: 2023826-2023-05295
• Device Sequence Number: 7108493
• Product Code: QCB
• UDI-Device Identifier: 00840311307890
• UDI-Public: 00840311307890
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: VTICM5_12.6
• 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: 11/09/2023
• Supplement Date Received by Manufacturer: 12/12/2023; 07/02/2024; 07/23/2024
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 12/15/2023; 07/09/2024; 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2023
• 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
• Patient Age: 44 YR
• Patient Sex: Female