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

Model Number	VTICM5 13.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that an implantable collamer lens of unknown model and size was implanted into the patient's left eye (os) on an unknown date.Elevated iop and narrow angles were reported.The lens remains implanted and the patient does not want the lens to be removed.No further information has been provided.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
(b)(4).Claim#: (b)(4).
Additional Manufacturer Narrative
Claim# (b)(4).
Additional Manufacturer Narrative
B5: the reporter indicated that 13.2mm vticm5 13.2 implantable collar lens of -13.0/1.0/177 (sphere/cylinder/axis) was implanted into the patient's left eye (os) on an unknown date.Elevated iop and narrow angles were reported.Reportedly the lens has been explanted at an unknown date.H6:4627 added and 2199 omitted for correction.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: the reporter indicated that 13.2mm vticm5 13.2 implantable collar lens of -13.0/1.0/177 (sphere/cylinder/axis) was implanted into the patient's left eye (os) on (b)(6) 2022.Elevated iop and narrow angles were reported.Reportedly the lens has been explanted on (b)(6)2023.The lens was replaced with a smaller length lens.Problem resolved.(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 enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 16000874
• Report Number: 2023826-2022-04424
• Device Sequence Number: 4370278
• Product Code: QCB
• UDI-Device Identifier: 00841542116992
• UDI-Public: 00841542116992
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/17/2022
• 2 Devices were Involved in the Event: 1 2

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: 04/30/2024
• Device Model Number: VTICM5 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 11/17/2022
• Supplement Date Received by Manufacturer: 12/22/2022; 03/30/2023; 04/29/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 01/21/2023; 04/26/2023; 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown