MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED PUREVISION (BALAFILCON A) CONTACT LENS; LENSES, SOFT CONTACT, EXTENDED WEAR

Lot Number R88529687

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

Patient Problems Bacterial Infection (1735); Corneal Ulcer (1796); Keratitis (1944); Pain (1994); Red Eye(s) (2038); Swelling (2091); Excessive Tear Production (2235)

Event Date 09/02/2019

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.A review of the manufacturing records concludes that the product was manufactured, packaged and released according to global and plant product specifications.Based on all information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A distributor reported that on the second day of wearing lenses, a consumer experienced redness, pain and swelling of the right eye.The symptoms persisted after the lens was removed.The following day, the consumer visited a hospital and the doctor informed there was corneal ulceration on the right eye.Additional information was obtained from the consumer.The consumer reported not being able to open the right eye and experienced tearing.The consumer reported he was treated with levofloxacin and tobramycin eye drops as well as ofloxacin eye cream.The consumer did not remember the treating doctor's information; however, provided medical documentation which shows bacterial keratitis in the right eye as the diagnostic conclusion.The documentation also indicated the consumer was treated with levofloxacin and physiological saline.

• Brand Name: PUREVISION (BALAFILCON A) 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 st; rochester, NY 14609 ; 5853386853
• MDR Report Key: 9413337
• MDR Text Key: 174299456
• Report Number: 0001313525-2019-00194
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/01/2005,09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/06/2021
• Device Lot Number: R88529687
• 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
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 12/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR