MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED PUREVISION MULTI-FOCAL CONTACT LENS; LENSES, SOFT CONTACT, EXTENDED WEAR

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

Patient Problems Abscess (1690); Bacterial Infection (1735); Conjunctivitis (1784); Corneal Edema (1791); Corneal Scar (1793); Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Unspecified Infection (1930); Inflammation (1932); Iritis (1940); Keratitis (1944); Neovascularization (1978); Pain (1994); Red Eye(s) (2038); Loss of Vision (2139); Excessive Tear Production (2235); Ptosis (2620)

Event Date 01/25/2016

Event Type  Injury  

Manufacturer Narrative

Consumer indicated as the event occurred a few years ago they are unable to confirm the product lot information or return the product.Additional medical information has been requested, but not received.The corneal specialist indicated they attributed the event to contact lens wear.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

Medwatch report received from fda, mw5086805.Through the medwatch program, the consumer reported they wore extended wear lenses for years prior.They followed all instructions provided by the doctor and developed an eye infection in the right eye.The consumer reported that the bacteria destroyed their cornea and they had several procedures performed in an attempt to save the cornea, including ¿gluing holes in the cornea¿, amino patches, removal of the contact lens from the eye, yag procedure and lens implants.Follow up with the consumer confirmed that after the eleventh day of wearing the lens she felt terrible pain and was seen by an ophthalmologist who treated her for a bacterial infection and prescribed antibiotics.The consumer was also referred to a corneal specialist who removed her crystalline lens and had an iol implanted.Follow up with the ophthalmologist confirmed the patient typically wears the contact lenses 30 days at a time and will then take a 2-3 day break.The complaint lenses had been in the consumers eyes for 2 weeks without being removed.The doctor confirmed the patient visited the office after believing they had developed a stye on the right upper eyelid.The patient self-treated with over the counter stye medication every 2 hours for 2 days.Two days prior to the event the consumer observed a white ¿spot¿ on their cornea had developed.Their visual acuity was considered ok, however the consumer was experiencing tearing, light sensitivity, pain radiating up across forehead, redness nasally and foreign body sensation.The patient kept dabbing their eyes and did warm compresses.The ophthalmologist confirmed the consumer had visited a different doctor and was diagnosed with acute iritis and bacterial infection.The right eye had no view.The ophthalmologist observed the consumer had mild ptosis in the right upper lid, 3-4+ injections and a very large 8+mm dense ulceration, epithelial defect.Follow up with the corneal specialist showed that the patient was examined on the same day as the ophthalmologist.They presented with symptoms of pain, and "white thing¿ seen in the right eye.The corneal specialist observed right eye injection, conjunctivitis, other anterior segment abnormalities, corneal edema, central corneal staining, a corneal abscess that penetrated bowman's membrane and left a residual scar.The patient had an infectious corneal ulcer in the central 6 mm of the cornea.The specialist confirmed they observed microbial keratitis and neovascularization (however the new blood vessels did not extend into the central 6 mm of the cornea).There was permanent loss of vision.The provider removed the lenses from the patient eye, which had been in the eye for two consecutive weeks.Cultures were taken and resulted in pseudomonas aeruginosa.The patient was treated for several years, with fortified tobramycin, fortified vancomycin, atropine and they received a corneal transplant in the right eye.The patient has recovered.The specialist attributed the event to contact lens wear.It was confirmed the event was not life threatening, but vision threatening.It did result in permanent impairment of a body function or permanent damage to a body structure, and did necessitate medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.Additional medical information has been requested, but not received.

• Brand Name: PUREVISION MULTI-FOCAL CONTACT LENS
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): BAUSCH & LOMB INCORPORATED; 1400 north goodman street; rochester NY 14609
• Manufacturer Contact: jennifer gamet ; 1400 north goodman street; rochester, NY 14609 ; 5853386853
• MDR Report Key: 8749184
• MDR Text Key: 149677360
• Report Number: 0001313525-2019-00103
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 60 YR