MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED SOFLENS DAILY DISPOSABLE CONTACT LENS; LENS, CONTACT, DISPOSABLE

Model Number SDD-040030PKR

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Iritis (1940)

Event Type  Injury  

Manufacturer Narrative

The complaint sample involved with this report was requested, but not yet received.The consumer did send sealed product with the same lot number.That product was returned and evaluated.All parameters were within specification.A review of the device history log is currently in progress.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A consumer reported that their left eye suffered from inflammation after wearing a soflens daily disposable lens.After an appointment with a doctor, the consumer stated that a diagnosis of iritis with an unknown source was given.This diagnosis was provided to the consumer around november and the doctor did not recommend any medical intervention or treatment.The consumer stated that the eye has recovered.Additional medical information was requested, however the consumer has refused to provide additional details as well as the doctor's contact information.

Manufacturer Narrative

A review of the manufacturing records was completed and 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.

• Brand Name: SOFLENS DAILY DISPOSABLE CONTACT LENS
• Type of Device: LENS, CONTACT, DISPOSABLE
• Manufacturer (Section D): BAUSCH & LOMB INCORPORATED; 1400 north goodman street; rochester NY 14609
• MDR Report Key: 10535826
• MDR Text Key: 207126958
• Report Number: 0001313525-2020-00122
• Device Sequence Number: 1
• Product Code: MVN
• Combination Product (y/n): Y
• PMA/PMN Number: K061157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2024
• Device Model Number: SDD-040030PKR
• Device Lot Number: W92011746
• 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: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other