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

Model Number	VT585U
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 11008951
• Report Number: 3004750704-2020-00069
• Device Sequence Number: 753351
• Product Code: LZP
• UDI-Device Identifier: 05050474547063
• UDI-Public: (01)05050474547063(17)220331(10)028719
• Combination Product (Y/N): Y
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P110007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 01/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention