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

Model Number	VTICM513.2
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Iritis (1940)
Date of Event	01/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information unknown.Adverse event problem: patient related factor.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm vticm513.2 implantable collamer lens of -11.5/3.0/093 (sphere/cylinder/axis) was implanted into the eye of a patient with pre-existing glaucoma on (b)(6) 2022.Pigment dispersion and iritis were observed.Cause of the event is both a unknown and a patient related factor.Reportedly the status of the eye is, "mostly quiet" and "tapering prednisolone inititated latanoprost in my opinion best irrespective of pigment dispersion, iritis.".
Additional Manufacturer Narrative
B5 - "reportedly, 'both icls were removed tuesday (b)(6) 2023 for persistent iop issues from pigment dispersion.Maximal medical therapy had been tried, as well as slt laser for the left.'" should be added to the initial mdr.D6b - explant date: (b)(6) 2023 should be added to the initial mdr.H6 - health effect - impact code: 4627 should be added to the initial mdr.Claim #(b)(4).
Additional Manufacturer Narrative
Additional information: b5: the reporter indicated that a 13.2mm vticm513.2 implantable collamer lens of -11.5/3.0/093 (sphere/cylinder/axis) was implanted into the eye of a patient with pre-existing glaucoma on (b)(6) 2022.Pigment dispersion, pressure spikes, and iritis are observed.Reportedly the status of the eye is, "mostly quiet" and "tapering prednisolone initiated latanoprost in my opinion best irrespective of pigment dispersion, iritis." reportedly, 'both icls were removed tuesday (b)(6) 2023 for persistent iop issues from pigment dispersion.Maximal medical therapy had been tried, as well as slt laser for the left.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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 16479533
• Report Number: 2023826-2023-00722
• Device Sequence Number: 3199192
• Product Code: QCB
• UDI-Device Identifier: 00841542116824
• UDI-Public: 00841542116824
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: VTICM513.2
• 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: 02/02/2023
• Supplement Date Received by Manufacturer: 04/13/2023; 04/18/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 04/17/2023; 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female