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

Model Number	VTICM5_12.6
Medical Device Problem Codes	Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens, -12.00/+1.5/089 (sphere/cylinder/axis), into the patients right eye (od).The lens had excessive vaulting and shallow ac.The lens remained implanted.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
A2: unk a3: unk a4: unk a5: unk a6: unk b3: unk d6a: unk d6b: unk h6 - work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
Additional Manufacturer Narrative
Additional data: h6: health impact- clinical code: 4581 - significant reduction of irido-corneal angles.Corrected data: b5: the reporter indicated the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens, -12.00/+1.5/089 (sphere/cylinder/axis), into the patients right eye (od) on (b)(6) 2023.The lens was removed on (b)(6)2 023 due to excessive vaulting and significant reduction of irido-corneal angles.The lens was replaced with a shorter lens and the problem was resolved.The ac had more stable depth after exchange, normal iop, vault and ac depth much improved.The cause of the event was due to patient-related factor.The device did not fail to perform as intended.Claim # (b)(4).
Additional Manufacturer Narrative
Corrected data: b5-the reporter indicated that the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens of diopter -12.00/2.0/092 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6) 2023.The patient experienced excessive vaulting and significant reduction of iridocorneal angles.On (b)(6) 2023 the lens was explanted.On the same day separate surgery a shorter length lens was implanted and the problem was resolved.Status of eye: "ac much more stable depth after exchange, normal iop, vault and ac depth much improved".The reporter indicated the cause of the event was a patient related factor and the device did not fail to perform as intended.H6-health effect - impact code: "4629" should be removed and "4627" should be added.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: h6- medical device problem code: "1494- off label use (pre exisiting: progressive myopia)" should be added.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: 17962098
• Report Number: 2023826-2023-04552
• Device Sequence Number: 15359321
• Product Code: QCB
• UDI-Device Identifier: 00841542115254
• UDI-Public: 00841542115254
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 09/28/2023

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: 12/31/2023
• 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: Not provided
• Supplement Date Received by Manufacturer: 11/14/2023; 01/09/2024; 01/19/2024
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 12/01/2023; 01/09/2024; 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female