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

Model Number	VTICM5_13.7
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.7mm vticm5_13.7 implantable collamer lens of diopter -8.0/3.0/091 (sphere/cylinder/axis) as an exchange lens into the patient's right eye (od) on (b)(6) 2024.Reportedly, "lens implanted and removed as the surgeon felt that even a 13.7 size lens was small." the lens was explanted on an unknown date.The problem was resolved.The cause of the event was reported as unknown.
Additional Manufacturer Narrative
A4-a6: unk.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
B1 - corrected to: product problem (e.G., defects/malfunction) in the intial mdr.B2 - required intervention to prevent permanent impairment/damage should be removed from the initial mdr.B5 - corrected to: "the reporter indicated that the surgeon implanted a 13.7mm vticm5_13.7 implantable collamer lens of diopter -8.0/3.0/091 (sphere/cylinder/axis) as an exchange lens into the patient's right eye (od) on (b)(6) 2024.Reportedly, "lens implanted and removed as the surgeon felt that even a 13.7 size lens was small." the lens was implanted and removed intraoperatively on (b)(6) 2024.Reportedly, "he is fine and happy after removal of icl." the problem was resolved.The cause of the event was reported as unknown." in the initial mdr.D6b -explant date: (b)(6) 2024 should be added to the initial mdr.H1- corrected to: malfunction in the initial mdr.H6 - health effect - impact code: 2199 should be added to initial mdr.H6 - health effect - medical device problem code: 3189 should be added to initial mdr.Claim # (b)(4).
Additional Manufacturer Narrative
D4 - model #: vticm5_13.2 corrected to vticm5_13.7.Claim #(b)(4).
Additional Manufacturer Narrative
H3 - device evaluation: the lens was returned dry in a microcentrifuge vial.Visual inspection found haptic bent/deformed to the lens.Dimensional inspection found that the returned lens did not meet original values measured at the time of manufacturing.Claim # (b)(4).
Additional Manufacturer Narrative
H6 - type of investigation 3331 - device history record (dhr) review: the dhr review indicates that the product has been manufactured within the established process parameters and that there is no indication that the manufacturing and/or 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 ; 6263037902
• MDR Report Key: 19001457
• Report Number: 2023826-2024-01472
• Device Sequence Number: 8434541
• Product Code: QCB
• UDI-Device Identifier: 00840311315628
• UDI-Public: 00840311315628
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/15/2025

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 Model Number: VTICM5_13.7
• 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: 03/12/2024
• Supplement Date Received by Manufacturer: 04/05/2024; 06/10/2024; 11/12/2024; 02/11/2025
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 04/05/2024; 06/10/2024; 02/07/2025; 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male