MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. HEALON ENDOCOAT; OVDS

Model Number VT585U

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

Patient Problem Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

Additional information: age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.Date of event: unknown, information not provided.Implant date: not applicable as this is not an implantable device.Explant date: not applicable as this is not an explantable device.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

Received report from a doctor's office which indicated three of their patients experienced toxic anterior segment syndrome (tass).They provided the two lot numbers involved in the three cases.However, at the time of this report they did not indicate which lot number correlated with which patient.Follow-up was performed to get additional details.However the customer only provided the doctors names and indicated that dr.(b)(6) had two patients and dr.(b)(6) had one patient.Dr.(b)(6) event is captured for this suspect lot number 028719 in this medwatch report.As described above, the patient experienced toxic anterior segment syndrome (tass).Although not specified, it¿s important to note the reported event normally requires medical intervention to resolve.No further information was provided.Another mdr report is submitted for the other suspect lot number.

Manufacturer Narrative

This investigation includes: ¿review of the manufacturing batch record for those characteristics that would potentially relate to the observations.¿review of the product testing to confirm, specification adherence (sterility, particulates, ph, endotoxin, and osmolality).¿review of the complaint database for similar reported events.Conclusion: based on the review of the batch records and manufacturing process, this occurrence is likely, not associated with a manufacturing assignable cause.Review of the complaint database indicates, there have been no other similar complaints for lot 028719.This complaint appears to be an isolated incident.Recommendations: since the root cause is likely, not related to the manufacturing process.And the report does not indicate a trend.No further actions are recommended at this time.Lifecore will continue to monitor and trend complaints of this type.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: HEALON ENDOCOAT
• Type of Device: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 11008951
• MDR Text Key: 221533989
• Report Number: 3004750704-2020-00069
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474547063
• UDI-Public: (01)05050474547063(17)220331(10)028719
• Combination Product (y/n): Y
• PMA/PMN Number: P110007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: VT585U
• Device Catalogue Number: VT585U
• Device Lot Number: 028719
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention