MAUDE Adverse Event Report: LIFECORE BIOMEDICAL, LLC VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE; AID, SURGICAL, VISCOELASTIC

Catalog Number 0004520066

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

Patient Problems Corneal Edema (1791); Clouding, Central Corneal (2228)

Event Date 03/03/2020

Event Type  Injury  

Manufacturer Narrative

The initial mdr and supplemental follow up 1 were submitted to the fda on time under manufacturing report number 3002037047-2020-00007.Upon confirmation of the reported product lot manufacturer, this report is being resubmitted under the correct manufacturing report number.The returned sample was confirmed to not be a manufacturing site product therefore, no further product evaluation was performed.Batch records were reviewed and all testing results met specifications for this lot code at the time of release.Additionally, there were no deviations noted during the batch record review.Complaint trending was reviewed for the lot code provided and no similar complaint was found.A root cause could not be determined.Based on the review of the batch records and manufacturing process, this occurrence is not likely associated with a manufacturing assignable cause.This complaint appears to be an isolated occurrence from a single end user.The complaint could not be confirmed based on the sample evaluation.Based on the investigation, the lack of additional complaints for this lot, the returned sample and the acceptable batch record review, no further action is warranted at this time.The manufacturer internal reference number is: (b)(4).

Event Description

A health professional reported that viscoelastic product was injected into an eye during a cataract surgery that had just previously received an injection of lidocaine 1% mpf when it was noted that the cornea and subcapsular lens became cloudy and edematous prompting the surgeon to abort the surgery.Follow up activity is scheduled in order to determine when the patient's procedure can be restarted.Additional information has been requested.Additional information received further clarified that upon day one post operative follow up examination, the patient's eye had greatly improved.The patient's procedure will be rescheduled once it is understood what happened in this reported event.

Manufacturer Narrative

Additional information is provided in section d.4.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received from the reporting physician indicated that the associated eye is doing well.

• Brand Name: VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Type of Device: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): LIFECORE BIOMEDICAL, LLC; 3515 lyman boulevard; chaska MN 55318
• MDR Report Key: 10259541
• MDR Text Key: 203136245
• Report Number: 2184002-2020-00005
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• PMA/PMN Number: P840064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 0004520066
• Device Lot Number: 028154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIDOCAINE 1% MPF.; OCUCOAT.
• Patient Outcome(s): Other