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

Model Number VICM5_12.6

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

Patient Problems Iritis (1940); Toxic Anterior Segment Syndrome (TASS) (4469)

Event Date 02/26/2024

Event Type  Injury  

Event Description

The surgeon implanted a 12.6mm vicm5 -8.00d implantable collamer lens, into the patient's right eye (od) on (b)(6) 2024.During lens implantation the icl was manually extracted with forceps and reloaded into a new injector followed by successful placement.The surgeon reports during implantation the icl made contact with the iris aggressively and possibly with the adjacent conjunctiva.On day 3 an above normal inflammation was noted with presentation of iritis and hypopyon along with report of tass.On (b)(6) 2024 an anterior chamber tap was performed with fluid sent for bacterial culture.On the same day intravitreal antibiotics of vancomycin and ceftazidime were given by the retinal specialist.The reporter did not provide identification of microorganisms.By (b)(6) 2024, the patient was noted as "recovered completely" with hypopyon resolved.Atropine was given for dilation and vision reportedly improved to 20/40+1.The lens remains implanted.The reporter states the cause of the event was unknown.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

A4: unk.A5: unk.A6: unk.D6b: na.Health effect impact code - additional medications: 4644 - vancomycin, ceftazidime.Work order search: no similar complaint was reported for units within the same lot.Manufacturer narrative: a review of the device labeling was completed.Iritis, hypopyon and infection are identified in the labeling as known potential adverse events following icl implantation.The evo/evo+ icl directions for use (dfu) states under adverse events: as with implantation of other types of intraocular lenses, potential adverse events can include, but are not limited to infection, hypopyon and iritis.The dfu states under surgical precautions: a learning curve and individual surgeon variability was seen in the clinical trial in terms of removals and reinsertions of the icl lens at the time of surgery.Procedural factors including surgical technique, inadvertent intra-operative trauma and the use of pro-inflammatory substances into the eye may have contributed to the event.Toxic anterior segment syndrome (tass) is an acute sterile postoperative inflammation that can occur after uncomplicated or complicated intraocular surgery.While improper sterilization and contamination of surgical instruments remains the most common risk factor associated with tass, ocular viscoelastic, and improper preparation of antibiotics for intracameral injection may also lead to tass.An exact cause could not be determined as the event could be multifactorial in nature including patient and/or procedure related factors.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC 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: 18991248
• MDR Text Key: 338794116
• Report Number: 2023826-2024-01185
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542119146
• UDI-Public: 00841542119146
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2024

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: VICM5_12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2024
• Initial Date FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/13/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male