|
Model Number OPO73 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Keratitis (1944); Blurred Vision (2137); Toxic Anterior Segment Syndrome (TASS) (4469); Swelling/ Edema (4577)
|
Event Date 06/21/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Suspect medical device: customer provided possible suspect opo73 tubing lots include the following lots available in their inventory - 60289899, 60279912, 60297871, 60282067; however, customer could not associate a specific lot to the case.Therefore, the following fields listed below related to section d and h are unknown for the case.Lot number is unknown as it was not provided.Expiration date is unknown as the lot number was not provided.Unique identifier is unknown as the lot number was not provided.Manufacturer date is unknown as the lot number was not provided.The device is not returning for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.The clinic is reporting this adverse event only and did not request or require field service or clinical support.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
|
|
Event Description
|
It was reported that there were 6 cases of toxic anterior segment syndrome (tass).It was learned that for this event, the visual symptoms of blurry debilitating, found to have punctate keratitis and mild edema diffusely.Further follow-up confirmed that patient had tass.Treatment provided was intensive topical steroids.The following meds were also given but was noted as the doctor's standard care, prolensa everyday, inveltys 2x/day, moxifloxican 2x/day, artificial tears, every 1 hour.It was stated that current patient status is that patient doing well, resolved keratitis and edema, best corrected visual acuity (bcva) 20/20.Intraocular lens (iol) remains implanted.No additional medical or surgical intervention required.The other products are not being returned for evaluation.Additional information received noted that the customer investigated the cases.However, root cause for the tass has not been determined.No other information was provided.This report is 5 of 6 cases for tass capturing the event for the tubing pack.Separate reports are being submitted for each of the other products involved.
|
|
Search Alerts/Recalls
|
|
|