MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. HEALON 5 PRO; OVDS

Lot Number UNKNOWN

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

Patient Problems Intraocular Pressure Increased (1937); No Code Available (3191)

Event Date 08/31/2020

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.Date of event: unknown, not provided.Model# and catalog#: unknown, as lot number was not provided.Lot number: unknown, information not provided.Unique device identifier (udi #): unknown, as lot number was not provided.Expiration date: unknown, as lot number was not provided.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.Device manufacture date: unknown as lot number was not provided.(b)(4).Device evaluation: the complaint sample is not available for further evaluation.Therefore, no testing can be performed.Manufacturing records review: for this healon 5 pro, lot# was not provided and cannot be obtained, therefore, manufacturing record review cannot be performed.Historical data analysis: for this healon 5 pro, lot# was not provided and cannot be obtained, therefore, complaint history review cannot be performed.Conclusion: based on the information obtained, product malfunction cannot be confirmed.Johnson & johnson surgical vision will continue to monitor this type of complaints.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

The customer reported ¿really high post-op intraocular pressure (iop) following cataract surgery.The surgeon inadvertently used healon 5 pro in place of healon pro.The customer suggested that the issue is related to the similar names and syringes.The patient admitted to emergency room (er) where medication drops administered after incision was enlarged (3 burps).Reportedly patient is better post surgery.No additional information provided.

Manufacturer Narrative

Corrected data: in the initial mdr, section b3:, date of event was inadvertently left blank.Additional info: the following field has been updated accordingly.Section b3: date of event: (b)(6) 2020.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Correction info: based on further review, there was no incision enlargement performed on the patient.However, there were three incision burps.The procedure completed is not considered as a surgical intervention.The patient is reported to be doing better.The information has been reported in the initial reporting, med-watch 3004750704-2020-00049.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: HEALON 5 PRO
• Type of Device: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10659859
• MDR Text Key: 216391089
• Report Number: 3004750704-2020-00049
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): Y
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention