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

Catalog Number ASKU

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2020

Event Type  malfunction  

Manufacturer Narrative

The initial mdr, supplemental follow up 1 and supplemental follow up 2 were submitted to the fda on time under manufacturing report number 3002037047-2020-00003.Upon confirmation of the reported product lot manufacturer, this report is being resubmitted under the correct manufacturer report number.The returned product was visually inspected, but only the locking collar and the cannula sheath were received.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.No similar complaint was found.A root cause could not be determined.Review of the records determined there were no deviations or comments related to product formulation that would indicate an issue with damaged units in regards to the cannula.The cannula component was used in five other finished good lots.There are no other complaints for any of the five lots that used the same cannula lot number.Syringe units are 100% visually inspected post-fill.Visual inspection and defect criteria are subjected to two 100% inspections prior to packaging.The qci inspections performed at final packaging prior to release met all criteria.Due to the lack of product returned regarding the observed cannula damage, no further assessment was performed.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 evaluation 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 a viscoelastic syringe cannula was not sealed into the base and fell apart.Procedure details information is unknown.No patient harm or patient consequence was reported.Additional information has been requested.Additional information received further stated that the threaded part that secures the two items together was broken and the cannula could not be attached to the base.Additional information is not anticipated for this report.

• Brand Name: VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Type of Device: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): LIFECORE BIOMEDICAL, LLC; 3515 lyman boulevard; chaska MN 55318
• Manufacturer (Section G): LIFECORE BIOMEDICAL, LLC; 3515 lyman boulevard; chaska MN 55318
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514979
• MDR Report Key: 10258210
• MDR Text Key: 203136984
• Report Number: 2184002-2020-00004
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/10/2020

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: ASKU
• Device Lot Number: 028148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2019
• 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