MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA TORIC INTRAOCULAR LENS; LENS, INTRAOCULAR, TORIC OPTICS

Model Number MX60T

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/20/2019

Event Type  Injury  

Manufacturer Narrative

The lens was returned for evaluation.Visual inspection found that the lens optic had been cut or torn into three pieces.One haptic was bent.The cause of the damage could not be determined and functional testing could not be performed as a result of the damage.A device history record (dhr) review did not find any nonconformities or anomalies related to this complaint.Based on the information provided, a root cause for the reported event could not be conclusively determined.

Event Description

It was reported that a lens was explanted from the patient's right eye approximately 5 months post-implant surgery.Though initially believed to be due to lens opacity and residual astigmatism, the patient's lens was actually explanted due to dislocation.The replacement lens for the patient's eye was of the same diopter but different model.It was stated that the patient had no pre-existing ocular conditions.Regarding prognosis, the patient is said to be doing well following the lens exchange.

• Brand Name: ENVISTA TORIC INTRAOCULAR LENS
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• 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: tes proud ; 1400 north goodman street; rochester, NY 14609 ; 5853388549
• MDR Report Key: 8800231
• MDR Text Key: 151360584
• Report Number: 0001313525-2019-00115
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P910056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• 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: MX60T
• Device Catalogue Number: MXUT125+250
• Device Lot Number: 3861501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2018
• 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): Other
• Patient Age: 64 YR