MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

Model Number MX60E

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

Patient Problems Blurred Vision (2137); Visual Disturbances (2140); Eye Pain (4467)

Event Date 10/10/2018

Event Type  Injury  

Event Description

Reportedly, eight months after having an intraocular lens (iol) implanted into the right (od) eye, the patient presented with glare, glinting, and a blurry spot in the vision.The patient stated there are occasional headaches, as well as eye pain, strain, or a tugging sensation on the right side of the eye.The original implanting surgeon was unsure of the likely cause of the event stating that despite achieving 20/20 uncorrected visual acuity, the patient notes a constant temporal reflection.Surgeon¿s diagnosis was dry eye, (b)(6) dysphotopsia, and blepharitis.A successful lens exchange was performed by a second surgeon, approximately 3 years after original implant using a different model and diopter lens.In the secondary surgeon¿s opinion, the most likely cause of event is unknown, but cited patient discomfort.The patient¿s outcome is good.

Manufacturer Narrative

Although requested, the device was not available for evaluation.The lot history, trend analysis, risk analysis, and directions for use were considered acceptable with the product performing within anticipated rates.The device history record (dhr) review did not find any non-conformities or anomalies related to this event.Based on the information provided, a root cause could not be determined.

Manufacturer Narrative

Although requested, the device was not available for evaluation.The lot history, trend analysis, risk analysis, and directions for use were considered acceptable with the product performing within anticipated rates.The device history record (dhr) review did not find any non-conformities or anomalies related to this event.Based on the information provided, a root cause could not be determined.

Event Description

Reportedly, eight months after having an intraocular lens (iol) implanted into the right (od) eye, the patient presented with glare, glinting, and a blurry spot in the vision.The patient stated there are occasional headaches, as well as eye pain, strain, or a tugging sensation on the right side of the eye.The original implanting surgeon was unsure of the likely cause of the event stating that despite achieving 20/20 uncorrected visual acuity, the patient notes a constant temporal reflection.Surgeon¿s diagnosis was dry eye, (b)(6) dysphotopsia, and blepharitis.A successful lens exchange was performed by a second surgeon, approximately 3 years after original implant using a different model and diopter lens.In the secondary surgeon¿s opinion, the most likely cause of event is unknown, but cited patient discomfort.The patient¿s outcome is good.

• Brand Name: ENVISTA 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: shayan habibi ; 21 north park place blvd., jambalana drive; clearwater, FL 33759
• MDR Report Key: 13603023
• MDR Text Key: 286153351
• Report Number: 0001313525-2022-00024
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: MX60E
• Device Catalogue Number: MX60E2150
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female