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 Codes	Inflammation (1932); Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	03/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).The ovd is not an implantable device.If explanted; give date: n/a (not applicable).The ovd is not an implantable device; therefore, not explanted.Concomitant medical products: model li61a0 intraocular lens sn: (b)(4) is a non-johnson & johnson surgical vision device.The product is not returning for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Device manufacture date: unknown.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that post-surgery involving healon endocoat ophthalmic viscosurgical device (ovd), the patient had postoperative infection in the left eye.The symptoms were described as greasy spot in vision, lots of floaters, blurred vision, redness and tearing.The patient was prescribed ofloxcin, durezol, ilevero and alphagan medications.The patient was also referred to a retinal specialist.Reportedly, patient's eye feels better, and can see a little better.Patient¿s vision was noted as hand motion only.Customer indicated that the product is not available for return.No further information was provided.
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 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: 8547506
• Report Number: 3004750704-2019-00012
• Device Sequence Number: 13553108
• Product Code: LZP
• UDI-Device Identifier: 05050474547063
• UDI-Public: (01)05050474547063(17)200930(10)027785
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P110007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2020
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: VT585U
• Device Catalogue Number: VT585U
• Device Lot Number: 027785
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MODEL LI61A0 INTRAOCULAR LENS SN: (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Date Report Sent to FDA: 01/01/2005