MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED RENU SENS. MULTI-PURPOSE SOL.(MILAN); ACCESSORIES, SOFT LENS PRODUCTS

Lot Number 222

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

Patient Problems Keratitis (1944); Corneal Infiltrates (2231); Eye Infections (4466)

Event Date 03/16/2022

Event Type  Injury  

Manufacturer Narrative

Device has been requested for return, but not received.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A retailer reported that a consumer used a solution and experienced pain in their left eye.They visited the doctor who treated them with chloramphenicol drops.When the drops did not work they were referred to a specialist and were diagnosed with corneal inflammation.The patient was admitted to a hospital for 1 week and received an unknown antibiotic treatment for the eye due to confirmed pseudomonas bacteria.The patient has returned to work but has not fully regained their sight.Medical records were received and confirmed the patient was admitted to the hospital after two days of pain and redness in the left eye.The patient had continued to wear contact lenses until the day before being admitted.The consumer was prescribed chloramphenicol drops and a bacteriology was performed as it was suspected the patient had severe keratitis.Upon intake patient had left eye visual acuity of 0.05/ft 1 uncorrected, 0.05 (-6.5).Examination showed the consumer had severe injection, central to the cornea white infiltrates were observed, almost circular like a mirror-inverted c clearing and thinning centrally.Partial fluorescein recording showed diameter of 4x4mm, and edema was seen in the surrounding stroma.There was a little fibrin right behind the infiltrate.The patient was treated with an hour drip of zinacef and fortified garamycin eye drops.Once the results of the bacteriology showed pseudomonas zinacef was discontinued and the patient was treated with cilox eye drops, fortified garamycin and cilox eye drops x 24 for 5 days.Upon discharge a week later the patient was treated with cilox eye drop 10x daily, ointment, cyclopentolate 2 times a day and artificial tear fluid as needed.The patient was told they could use paralgin forete, paracet and ibux (ibuprophen) for pain.The visual acuity visual acuity was hb 30cm with pressure of 10/6 mmhg.The left eye still had severe injection, with central corneal infiltrates measured 4mm (h) and 3.5mm (w).Corneal edema was 6mm (h) and 5.5 mm (w).There was no hypopyon or fibrin noted.The iris was observed to be hyperemic, and there was no access to the retina.It was confirmed that the patient was diagnosed with severe pseudomonas keratitis with central infiltrate.Patient followed up 12 days after admission and was instructed to continue use of cilox drops and chloramphenicol ointment.3 days later the patient was given a bandage lens and instructed to use chloramphenicol 5 times a day.The patient discontinued the bandage lens after 12 days.The patient returned a month and half after admission and the exam showed that the epithelia has begun to recover.They were instructed to use chloramphenicol ointment 2 times a day and monopex drop 1 time a day and referred for potential laser treatment.Two months after admission the patient confirmed the pain is gone, however their vision has not improved.Visual acuity was reported os:0.13++ with correction of -6.00.The cornea has large central damage and thinning with vascular growth is at 12-2 o''clock and at 5 o''clock.The medical records conclude the pseudomonas keratitis caused severe visual impairment, however it is possible that it could improve.Contact lenses could potentially improve the visual acuity.The patient was instructed to use ointment 2x and to use simplex ointment, and monopex x1 to counteract the vascular growth.Patient was instructed to return in a few months for reexamination.

Event Description

Additional information was received that two months from the event the patient has reported they have not gain their full vision, however they returned to work fulltime.It was also reported that the patient is uncertain if the device is related to the event.

Manufacturer Narrative

Product was received and is currently undergoing evaluation.A review of the lot batch record and testing of retain samples concluded that the product was formulated and manufactured according to local and global specifications.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Manufacturer Narrative

Product was returned and evaluated.The results of that evaluation revealed that the solution met all chemical, biocidal and bioburden specification requirements and concluded that no product defect was found.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

• Brand Name: RENU SENS. MULTI-PURPOSE SOL.(MILAN)
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): BAUSCH & LOMB INCORPORATED; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB-IOM S.P.A; via pasubio 34; 20050 macherio; milan NY 20846 ; IT 20846
• Manufacturer Contact: jennifer gamet ; 1400 north goodman street; rochester, NY 14609 ; 5853386853
• MDR Report Key: 14827841
• MDR Text Key: 294783689
• Report Number: 0001313525-2022-00087
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K982775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/30/2023
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN CONTACT LENS
• Patient Outcome(s): Hospitalization
• Patient Sex: Male