MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED ULTRA (SAMFILCON A) CONTACT LENS; LENSES, SOFT CONTACT, DAILY WEAR

Lot Number R82018031

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

Patient Problems Cellulitis (1768); Corneal Scar (1793); Corneal Ulcer (1796); Dry Eye(s) (1814); Irritation (1941); Itching Sensation (1943); Pain (1994); Red Eye(s) (2038); Uveitis (2122); Loss of Vision (2139); Corneal Infiltrates (2231); Excessive Tear Production (2235)

Event Date 12/07/2018

Event Type  Injury  

Manufacturer Narrative

The product was discarded.A review of the lot device history records is in progress.Additional medical information has been requested but not received.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A doctor reported to a sales rep that a patient experienced redness, irritation, tearing and light sensitivity in both eyes and temporarily lost vision in their right eye after wearing contact lenses.The patient was seen by the doctor on (b)(6) 2018.After examination, a bulbar injection of the right eye and an anterior chamber reaction of 4 + cells + flare in the right eye were noted.The patient was diagnosed with unspecified acute and subacute iridocyclitis.The patient was advised to use a cold/warm compress, to temporarily suspend contact lens wear and was prescribed homatropine and pred forte to be used from (b)(6).The doctor indicated the likely cause of the event is anterior uveitis of unknown cause.The patient returned to the office on (b)(6) 2018 with continued pain and light sensitivity and elected to continue treatment with a different doctor.It was also reported the patient was under treatment of fml (fluorometholone ophthalmic suspension), tropicamide.5% and phenylephrine 2.5%.It is uncertain which doctor prescribed these medications.Additional information was obtained from the consumer.The consumer reported that they have recovered and are currently not wearing contact lenses.The consumer visited multiple doctors including an urgent care and emergency room.It was confirmed that one of the doctors was a glaucoma specialist who confirmed that the patient was not seen by their office for the symptoms experienced after wearing the contact lenses.Additional medical information has been requested from the remaining doctors but has not yet been received.

Manufacturer Narrative

A review of the device lot history was completed, and it was determined that there were no recorded irregularities within the lot.The review of the manufacturing records concludes that the product was manufactured, packaged and released according to global and plant product specifications.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

Additional information was received from a representative affiliated with the urgent care and emergency room where the patient was seen.The representative confirmed that the patient was seen at the urgent care on (b)(6) 2018 with itching, irritation, pain and difficulty opening their right eye.No drainage or trauma was observed; there was no associated diagnosis.The patient was treated with pataday and advised to follow up with their eye doctor or local er if they experienced visual changes.The next day, the patient visited the emergency room and presented with eye pain, eyelid pain and red eye.The patient was diagnosed with preseptal cellulitis of the right eye.They were prescribed tetracaine 0.5% drops and keflex 500mg capsules.The patient was discharged in stable condition.As described in the initial report, the patient was then treated from (b)(6) 2018 by an optometrist.Per the optometrist, the patient¿s event was not considered life threatening, did not result in permanent impairment of a body function or permanent damage to a body structure, and did not necessitate medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.Additional information was also received from another doctor seen by the patient.This doctor indicated that they first saw the patient on (b)(6) 2019.Upon examination, bulbar injection and anterior segment abnormalities of cells were observed in both eyes and central corneal infiltrates were observed in the right eye.The patient was diagnosed with anterior uveitis in both eyes and an infectious corneal ulcer located in the central 6mm of the cornea in the right eye.Lotemax gel was prescribed to treat the uveitis and vigamox was prescribed to treat the corneal ulcer.The doctor noted that the patient¿s eye issues occurred only when wearing the complaint lenses while also stating that the patient was not compliant with contact lens wear and care and that this is what caused the uveitis.The patient was seen for a follow up appointment on (b)(6) 2019 with this same doctor.The uveitis had resolved.The doctor observed a small scar on the patient¿s right cornea, inferior to the visual access and located in the central 6-8mm of the cornea.Dry eye was also noted.The doctor confirmed that the scar is not affecting the patient¿s vision.Finally, this doctor also reported that the event was not considered life threatening, did not result in permanent impairment of a body function or permanent damage to a body structure, and did not necessitate medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

Manufacturer Narrative

Product has been discarded.A review of the lot device history records is in progress.Based on all available information, no causal factors can be determined and no conclusion can be drawn.Corrected date of event and usage of device.

• Brand Name: ULTRA (SAMFILCON A) CONTACT LENS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): BAUSCH & LOMB INCORPORATED; 1400 north goodman street; rochester NY 14609
• MDR Report Key: 8499754
• MDR Text Key: 141480396
• Report Number: 0001313525-2019-00063
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• PMA/PMN Number: K131208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/25/2021
• Device Lot Number: R82018031
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OPTIFREE REPLENISH SOLUTION; OPTIFREE REPLENISH SOLUTION
• Patient Outcome(s): Other
• Patient Age: 25 YR