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

Model Number VTICM5_12.6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Uveitis (2122); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/19/2023

Event Type  Injury  

Manufacturer Narrative

Although requested, the device has not been returned to date.A review of the device labeling was completed.Elevated iop and pigment dispersion are identified in the labeling as known adverse events from icl implantation.The dfu adequately provides instructions for icl implantation and includes known adverse events associated with lens implantation.The dfu statements include: adverse reactions and complications due to or following surgery and implantation of any evo|evo+icl may include, but are not limited to: uveitis/iritis, iop elevation from baseline, iris pigment dispersion, secondary surgical intervention to remove the lens.An exact cause could not be determined as the event could be multifactorial in nature including patient and/or procedure related factors.H6- health effect- clinical code 4581: pigment dispersion h6 - type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.Claim# (b)(4).

Event Description

The reporter indicated that a 12.6mm vticm5 implantable collamer lens -4.00/+2.00/101 (sphere/cylinder/axis) was implanted into the patients left eye (os) on (b)(6) 2023.Bilateral sequential icl implantation was performed followed with an anti-inflammatory antibiotic drop po drop regimen.Pigment dispersion and prolonged postoperative anterior uveitis was reported.An anterior chamber reaction and elevated iop of 27mmhg (non-contact tonometry) was noted at 1mo post-op.On (b)(6) 2023 the lens was explanted with presentation of persistent ac inflammation.Findings at the last visit show bcva same as pre-op with patient continued use of steroid, antibiotic, and iop lowering drops.The patient has a pre-existing health history of asthma and covid infection.Based on clinic reported pre-op wtw & acd, the surgeon implanted a shorter lens length than suggested by the directions for use.In the reporter's opinion the cause of the event is unknown.If additional information is received a supplemental medwatch report will be submitted.

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.(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 muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18682471
• MDR Text Key: 335073672
• Report Number: 2023826-2024-00566
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/15/2024

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 Model Number: VTICM5_12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2023
• 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: CARTRIDGE MODEL: SFC-45 W/FTP, LOT# UNK; INJECTOR MODEL: MSI-PF, LOT# UNK
• Patient Outcome(s): Required Intervention
• Patient Sex: Female