TECNIS Odyssey Toric II IOL

Description of Event or Problem

It was reported that a preloaded multifocal toric intraocular lens (IOL) implanted in the patient's eye was subsequently explanted due to glare. No further information was provided.

Additional Manufacturer Narrative

Section A3a, A3b, A4, A5 and A6: Unknown, information was requested but not provided.Section B3: Date of Event: Unknown, not provided, but the best estimate date is between May 14, 2026 and Jul 6, 2026.Device Evaluation: The product testing could not be performed as the product was not returned. The reported complaint cannot be confirmed. Manufacturing Record Review: The manufacturing records for the product were reviewed. The product was manufactured and released according to specification. A search of complaints related to this Production Order (PO) was performed. The search revealed that no other complaints were received for this PO. Conclusion:Based on the investigation results, there is no indication of a product malfunction or product quality deficiency. The reported issue was not verified. Section H6: Health Effect - Impact Code: 4619 - Temporary Impairment (Glare).Attempts have been made to obtain missing information; however, to date, the information has not been provided.All pertinent information available to Johnson & Johnson Surgical Vision, Inc. has been submitted.