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

Model Number HEALON

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

Patient Problems Vitreous Loss (2142); Capsular Bag Tear (2639); Vitrectomy (2643)

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.Expiration date: unknown as product lot number was not provided.Udi # is unknown as product lot number was not provided.If implanted; give date: not applicable as the healon is not an implantable device.If explanted; give date: not applicable as the healon is not an implantable device.Phone: unknown/not provided.Device evaluation: since no sample was returned for investigation product evaluation is not performed and a product deficiency is not confirmed.Manufacturing record review: manufacturing record review cannot be performed since the lot number is unknown.A search of complaints related to lot number cannot be performed since the lot number is unknown.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.An attempt has been made to obtain missing information; however, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.Hengereer, f.H., dick, h.B., kohnen, t., and conrad-hengerer, i., (2015) assessment of intraoperative complications in intumescent cataract surgery using 2 ophthalmic viscosurgical devices and trypan blue staining.Journal of cataract refractive surgery, 41, p.714-718.

Event Description

The following article was received based on a literature review: assessment of intraoperative complications in intumescent cataract surgery using 2 ophthalmic viscosurgical devices and trypan blue staining.The publication reports 2 anterior capsule tear, one of the anterior tear radiated and caused posterior capsule rupture, same that resulted in vitreous loss.The procedure was converted to eec (extracapsular cataract extraction) with anterior vitrectomy and iol implantation at ciliary sulcus.In group 1 they used medium viscosity ophthalmic viscosurgical device (ovd) healon while in group 2 they used both medium viscosity and high viscosity healon.In group 1 there were capsule tears in 2 eyes and in 1 eye, the procedure was converted to eec (extracapsular cataract extraction) with anterior vitrectomy and iol implantation at ciliary sulcus.In group 2, there were no capsule tears.The study concluded that using 2 different ovds and placing the high-viscosity ovd centrally led to safe indentation of the anterior lens capsule and reduced the risk for continuous curvilinear capsulorhexis (ccc) enlargement and capsule tear during surgery.

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
• Type of Device: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9264828
• MDR Text Key: 170479842
• Report Number: 3004750704-2019-00057
• 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: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HEALON
• Device Catalogue Number: HEALON
• 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): Required Intervention