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

Model Number UNKNOWN

Device Problems Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.Date of event: unknown, not provided.Lot#: unknown/not provided.Catalog#: catalog # is unknown, as product lot number was not provided.  expiration date: unknown as product lot number was not provided.Udi #: udi # is unknown as product lot number was not provided.  if implanted; give date: n/a (not applicable).The healon endocoat is not an implantable device.If explanted; give date: n/a (not applicable).The healon endocoat is not an implantable device; therefore, not explanted.Facility name: unknown/ not provided.Address, city, state: unknown/ not provided.Postal code: unknown/ not provided.Device manufacture date: unknown, as the lot number of the device was not provided.(b)(4).An attempt has 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

It was reported that the doctor was seeing more cases of patient with iris prolapse, and wonders if it could be related to healon endocoat.No additional information provided.

Manufacturer Narrative

Additional information was received and it was learned that the doctor used less amount of ovd (ophthalmic viscosurgical device) during surgery.Once he returned to using the recommended amount of ovd he did not observe the iris prolapse.No other information was provided.The following field was updated accordingly: device code: updated from 2993 to 2949.Device evaluation: the device was not returned at the manufacturing site; therefore product testing could not be performed and the customer''s reported complaint could not be verified.Manufacturing records review: the lot number was not provided therefore the manufacturing records could not be reviewed.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.

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 capa-010215.

• 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: 8338294
• MDR Text Key: 136108752
• Report Number: 3004750704-2019-00001
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): Y
• PMA/PMN Number: P110007
• 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: 01/01/2005,11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other