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

Model Number	VTICM5_13.2
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6 - work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens -05.50/+1.0/088 (sphere/cylinder/axis) into the patient`s eye.The lens was removed due to large size and replaced with a shorter length lens.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
B5: the lens was removed due to excessive vaulting.The lens was replaced with a shorter length lens and the problem was resolved.The patient was happy.Claim # (b)(4).
Additional Manufacturer Narrative
Corrected data: b1: product problem b5: the reporter indicated the surgeon inserted and removed a 13.2mm vticm5_13.2 implantable collamer lens, -05.50/+1.0/088 (sphere/cylinder/axis) during the same surgery due to excessive vaulting.The lens was replaced with a shorter length lens and the problem was resolved.The patient is happy.H1: malfunction h6: health effect - impact code (f): 2199 h6: medical device problem code (a): 3189 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 ; 6263037902
• MDR Report Key: 18804155
• Report Number: 2023826-2024-00843
• Device Sequence Number: 17928014
• Product Code: QCB
• UDI-Device Identifier: 00840311311095
• UDI-Public: 00840311311095
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2024

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: 08/31/2026
• Device Model Number: VTICM5_13.2
• 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: Not provided
• Supplement Date Received by Manufacturer: 03/08/2024; 05/14/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 04/07/2024; 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2023
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown