MAUDE Adverse Event Report: BAUSCH + LOMB OCUCOAT VISCOELASTIC; AID, SURGICAL, VISCOELASTIC

Model Number CC065S

Device Problem Product Quality Problem (1506)

Patient Problem Capsular Bag Tear (2639)

Event Date 08/30/2022

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore an evaluation cannot be performed.Review of the video provided by the surgeon shows the posterior capsule tear open at or near the same time that a cluster of bubbles were released from the tip of the cannula, during the viscoelastic injection.Overinflating the bag with viscoelastic or some preexisting microscopic defect in the posterior capsule can blow out the bag.The cause of the tear cannot be determined due to unknown variables that could contribute to a posterior capsule tear, such as surgical conditions, patient related factors like disease, or other conditions of the eye that can increase the probability of a capsule rupture.The investigation is ongoing and a follow-up report will be submitted upon completion.

Event Description

Reportedly, there was posterior capsule rupture after a viscoelastic injection into the eye.Allegedly, there were more bubbles than usual.Reverse optic capture of intraocular lens (iol) and power adjustment of iol were performed.Patient outcome was normal and the eye looked good.

Manufacturer Narrative

Updated d4, g3, h2, h4, h6, h10./11.A review of the device history record (dhr) found no nonconformities or anomalies related to this complaint.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on all available information, the root cause could not be determined.

• Brand Name: OCUCOAT VISCOELASTIC
• Type of Device: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): LIFECORE BIOMEDICAL; 3515 lyman blvd.; chaska MN 55318
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 15528780
• MDR Text Key: 301024249
• Report Number: 0001313525-2022-00133
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CC065S
• Device Catalogue Number: CC065S
• Device Lot Number: 029742
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2022
• 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
• Treatment: HEALON GV, IOL CCLOTTO
• Patient Age: 64 YR