H6 - type of investigation - lens work order search: one similar complaint type event reported for units within the same lot.Manufacturer narrative: a review of the device labeling was completed.The dfu provides the surgeon instruction for complete ovd removal.Precaution: (6) after inserting this product, aspirate the viscoelastic substance completely from inside the eye.Do not use highly viscous viscoelastic substances that are difficult to aspirate completely.Under other defects there is a possibility of (3) foreign matter adhering to the lens surface.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.Claim#(b)(4).
|
The reporter indicated that the surgeon implanted a 13.2mm vicm5 -7.00 diopter implantable collamer lens into the patient's left eye (os) on (b)(6) 2024.The patient underwent bilateral sequential icl surgery.The msi injector delivery system was used but the viscoelastic type used during procedure was not provided.Tass was diagnosed.Diagnostics were performed and deposits identified on the back of the lens.It was also reported that onset of problem was 1 month after surgery and that additional procedures were performed: "ear side incision.Vertical fixation.Per last report, dated on (b)(6) 2024, the patient had no subjective symptoms and remains under observations.The lens remains implanted.In the reporter's opinion cause of the event is unknown.
|