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

Model Number VTICM513.2

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Intraocular Pressure Increased (1937); Iritis (1940)

Event Date 01/17/2023

Event Type  Injury  

Manufacturer Narrative

Patient information unknown.Adverse event problem: patient related factor.Claim# (b)(4).

Event 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.".

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).

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)
• Type of Device: 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
• MDR Text Key: 310628476
• Report Number: 2023826-2023-00722
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542116824
• UDI-Public: 00841542116824
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/02/2023
• Initial Date FDA Received: 03/03/2023
• Supplement Dates Manufacturer Received: 04/13/2023; 04/18/2023
• Supplement Dates FDA Received: 04/17/2023; 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female