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

Model Number	HEALON 0.85
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If implanted; give date: n/a (not applicable).Healon is not an implantable device.If explanted; give date: n/a (not applicable).Healon is not an implantable device.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that undefined blue strip presented while the doctor injecting healon 0.85 into patient's eye for cataract surgery.Reportedly, a foreign material came out the syringe halfway through the injection.The patient's eye was then rinsed and the foreign material was removed from the eye as the patient underwent a cataract surgery with intraocular lens implantation with no apparent complications.No additional information provided.
Additional Manufacturer Narrative
The visual inspection of the healon syringe/components did not indicate any parameter or component which was abnormal or out-of-specification.There was no indication that the ¿blue strip¿ was a coring particle from the blue rubber membrane.There were no particles, fibers, air bubbles or other material finds in the remaining healon solution which could explain the customers' report of a "blue strip".This investigation could not confirm the potential defect reported by the customer.Moreover, a visual inspection on retained products on healon lot# ud31099 was also performed.35 samples were investigated.No visible defects were found on the package, cannula or solution.The solution was clear and colorless.All components were included in the product, without defects.Cannula was without damage.No visible defects on the product box.The printing on the carton and labels are correct.Product deficiency was not found on retained samples.Manufacturing record review of the production order and related document revealed that the product was manufactured and released according to specifications.A search of complaints related to lot number ud31099 was performed.No complaints have previous been reported on this batch.The labeling review was completed and revealed that the directions for use (dfu) provide the customer with proper usage instructions and guidelines.No labeling changes are required.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are (b)(4) and (b)(4).

• Brand Name: HEALON
• Common Device Name: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7832599
• Report Number: 3004750704-2018-00048
• Device Sequence Number: 2013079
• Product Code: LZP
• UDI-Device Identifier: 00385445084212
• UDI-Public: (01)00385445084212(17)201231(10)UD31099
• Combination Product (Y/N): Y
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P810031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2020
• Report Date (Section F): 01/01/2005

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: HEALON 0.85
• Device Catalogue Number: 10290953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 10/15/2018; 10/25/2020
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 11/07/2018; 11/03/2020
• 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
• Date Report Sent to FDA: 01/01/2005