MAUDE Adverse Event Report: BAUSCH + LOMB UNKNOWN BAUSCH+LOMB INTRAOCULAR LENS

Model Number UNKNOWN

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

Patient Problems Corneal Edema (1791); Hemorrhage/Bleeding (1888); Retinal Injury (2048)

Event Type  Injury  

Manufacturer Narrative

Although requested, the consumer has declined to provide further information.It is unclear if the iol remains implanted as further information was not provided.Additionally, the device name, model, lot number, or serial number of the lens were not provided.Therefore, no product evaluation or device history records review can be performed.A review of the events submitted within the last five years for all intraocular lenses (iols) manufactured by bausch + lomb indicated that there is no trend associated with corneal edema.

Event Description

It was reported that the consumer is experiencing corneal edema and retinal bleeding following an unknown b+l intraocular lens (iol) implantation.The consumer was reportedly on corticosteroids.Patient had reportedly requested medical consult regarding the use of muro solution to treat her condition.Additional information including iol information has been requested; however, the consumer has declined to provide further details.

• Brand Name: UNKNOWN BAUSCH+LOMB INTRAOCULAR LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 north park place blvd; clearwater FL 33759
• Manufacturer Contact: stephanie anastasiou ; 21 north park place blvd.; clearwater, FL 33759
• MDR Report Key: 11862198
• MDR Text Key: 252297330
• Report Number: 0001313525-2021-00068
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other