MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED PUREVISION 2 MULTI-FOCAL CONTACT LENS; LENSES, SOFT CONTACT, EXTENDED WEAR

Lot Number R88529241

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

Patient Problems Conjunctivitis (1784); Corneal Abrasion (1789); Corneal Edema (1791); Corneal Scar (1793); Corneal Ulcer (1796); Unspecified Infection (1930); Inflammation (1932); Keratitis (1944); Acanthameba Keratitis (1945); Neovascularization (1978); Pain (1994); Red Eye(s) (2038); Blurred Vision (2137); Corneal Infiltrates (2231); Excessive Tear Production (2235)

Event Date 03/27/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A consumer reported to a sales rep that they woke up with eye pain and blurred vision in their left eye after wearing contact lenses and using a contact lens solution.The consumer visited their optometrist on (b)(6) 2019 and was referred to a surgery center where they were diagnosed with a corneal graze.A/b eye drops were prescribed to be used four times a day and systane as needed.The consumer was then seen by a different doctor within the surgery center on (b)(6) 2019 and was diagnosed instead with acanthamoeba keratitis.Later that day, they visited a hospital where confocal microscopy was performed and acanthamoeba keratitis was confirmed.Polyhexanide 0.02% and brolene drops were prescribed and the consumer was instructed to use systane eye drops as needed.The consumer was seen for a follow up appointment on (b)(6) 2019 and was advised to continue brolene and polyhexanide.On (b)(6) 2019 the consumer had another follow up appointment where they were told to discontinue use of the brolene but to continue with the polyhexanide.The consumer was last seen by their doctor on (b)(6) 2019 where they were told to continue the polyhexanide and for pain relief were prescribed panadeine forte and nurofen plus.The consumer has future follow up appointments with the hospital doctor and the optometrist.Additional medical information has been requested but not yet received.

Manufacturer Narrative

Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

The consumer was recently seen for a follow up appointment with one of the treating doctors.The consumer is now using an eye drop once a day for the next two months.They will return to this same treating doctor for additional testing in two months.The consumer also has a follow up appointment with a second treating doctor for a checkup at the end of the year.

Manufacturer Narrative

Corrected brand name and pm#/510(k).Additional information was received from the consumer.The consumer has discarded the lenses.Additional medical information has been requested but not received.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.

Manufacturer Narrative

Additional information was received from three of the four treating doctors.The second and third doctors attributed the event to the consumer not being compliant with contact lens wear and care.The consumer rinses their lenses and lens case in water.The third doctor states that acanthamoeba is present in the sydney water supply.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

Additional information was received from three of the treating doctors.The patient was examined on the same day initially by two of the doctors, each from a different office.The third doctors performed their examination two days later.The first doctor confirms that the patient has a history of fuchs endothelial dystrophy.The doctor indicates that the patient presented with a watery eye, sore, light sensitivity and xs lacrimation.The doctor observed left eye bulbar injection, other anterior segment abnormalities, corneal staining at 11 o¿clock and corneal infiltrates.The doctor confirms that the patient does not have an abrasion but does have a residual scar that is located in the central 6mm of the cornea.The doctor observed a corneal ulcer at 11 o¿clock in the left eye.Cultures were taken, but the results were not disclosed.It is uncertain if there is any permanent vision loss.The patient was diagnosed with acanthomoeba keratitis and was prescribed ocuflox, systane, chlorsig, phmb, brolene, cycliopentolate and panadol.The patient is still undergoing treatment.The event was not life threatening, however it did results in permanent impairment of a body function or permanent damage to a body structure and it did necessitate medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.The second doctor confirms that the patient has a history of fuchs endothelial dystrophy.The doctor indicates that the patient is not compliant with contact lens care as they wash their lenses with water.The patient presented with symptoms of pain, irritated red eye and photophobia.The doctor observed left eye corneal staining and conjunctivitis.The doctor observed a small rectangular corneal abrasion in their left eye located in the paracentral super cornea, there was no evidence of infiltrate or the appearance of a dendrite.Neovascularization was present, the doctor is unsure if the new blood vessels extend into the central 6mm of the cornea.The patient was prescribed ocuflox six times a day, chlorsig and systane every 1-2 hours.No cultures were taken.The patient is still under treatment and the doctor feels that contact lenses are the cause of this event.The doctor advised the patient to see their colleague in two days for a follow up appointment.The third doctor, performed an examination two days later in the same office as the second doctor.They observed that the patient was still significantly photophobic.The patient exhibited a pseudodendritic appearance of their left cornea and a widespread punctate corneal epitheliopathy.The doctor indicates that the corneal sensation was normal but there was concomitant limbal injection and a mild anterior chamber inflammatory reaction.The doctors observed that examination of the right external and anterior segment was normal.The patient was diagnosed with acanthomoeba keratitis.The doctor indicates that the most likely source of the acanthamoeba was from the patients contact lens via her contact lens cases.The contact lens case had been washed with water and acanthamoeba is present in the sydney water supply.The doctor also feels that the minor epithelial trauma she had experienced earlier in the week may have been the catalyst for development of the keratitis.The diagnosis was confirmed later in the day at the hospital.The patient was prescribed phmb and brolene ointment.The patient will need treatment for several months and has pending pcr results.The patient will need to wear eye glasses during treatment.

Manufacturer Narrative

Additional information was requested from two of the four treating doctors but not received.Information obtained from the third treating doctor attributed the event to the consumer not being compliant with contact lens wear and care.The consumer rinses their case and lenses in tap water and sleeps in lenses for one to two months.While the fourth attributed it to contact lens wear.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

Additional information was received from two treating doctors from different offices.Both doctors examined the patient on the same day.The first doctor confirmed that the patient has history of fuchs endothelial dystrophy.The doctor indicates the consumer is not complaint with proper contact lens wear and care as they rinse their lens case with tap water and sleep in their lenses for 1-2 months.Bulbar injection and conjunctivitis were observed in the left eye.Other anterior segment abnormalities were observed in the left eye, the specific abnormalities were not provided.Left eye corneal edema and corneal staining, located in the medial hemi field.A corneal ulcer was observed, located in the medial hemi field and was infectious.The doctor indicated that there will probably not be permanent vision loss.Cultures were taken and the results of the cultures came back negative.The patient was diagnosed with acanthomoeba keratitis.The patient is currently still under treatment and was prescribed phm3.The doctor believes that the likely cause of the event is from the patient rinsing their contact lens cases in tap water.The second doctor confirmed that the patient came to the office with symptoms of left eye acanthamoeba keratitis.The doctor observed left eye bulbar injection, conjunctivitis and upper lid tarsal conjunctival abnormalities (giant papillary conjunctivitis).No external lid/lash abnormalities were observed.Corneal edema and a corneal staining, was centrally located.The doctor observed a left corneal abrasion that left minor residual scar located in the central 6mm of the cornea, it did not penetrate bowman¿s membrane.The doctor reported that there was also a corneal ulcer located in the central 6mm of the cornea of the left eye.Cultures were taken which revealed acanthamoeba keratitis.The doctor indicates the ulcer was infectious.Microbial keratitis and neovascularization in the left eye were also detected.The new blood vessels do not extend into the central 6mm of the cornea.The doctor states there is no new corneal scar.It is uncertain if there is any permanent vision loss.The patient is still undergoing treatment and was prescribed phm3 and brolene.The doctor believes that the reported events occurred due to contact lens use.

• Brand Name: PUREVISION 2 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
• MDR Report Key: 8550947
• MDR Text Key: 143260685
• Report Number: 0001313525-2019-00075
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• PMA/PMN Number: P980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/01/2005,10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/05/2021
• Device Lot Number: R88529241
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIOTRUE MULTI-PURPOSE SOLUTION
• Patient Outcome(s): Other