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

Model Number TH55ML

Device Problem Contamination (1120)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/25/2020

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.(b)(6).Device evaluation: the sample is not available for further evaluation.Therefore, no testing can be performed, the reported event was not confirmed.However, the provided photos by the customer were evaluated by the product subject matter expert (sme).Per the sme evaluation of the photos: the particle appears to be a grey rubber coring particle or rubber particle remaining from the membrane manufacturing process.Under the bright lights the light gray would appear almost white.Coring is a known issue with a very low frequency.Coring can be exacerbated by not allowing the product to reach room temperature prior to use as the rubber is not as pliable at refrigerator temperatures compared with room temperature.This indicated in the direction for use (dfu) included in the product as follows: "refrigerated healon pro ovd should be allowed to attain room temperature (approximately 30 minutes) prior to use.¿ manufacturing records review: a manufacturing record review was performed and no deviation related to this complaint is reported in the manufacturing record.A search of complaint system revealed no other complaints have previously been reported on this batch.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a whitish particle was found in the eye during injection of the healon pro.It was indicated that the particle was removed by the surgeon and it subsequently dissolved in the balanced salt solution (bss).No further information was provided.

• Brand Name: HEALON PRO
• Type of Device: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC.; rapsgatan; uppsala 751 8 2; SE 751 82
• Manufacturer Contact: somyata nagpal ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478200
• MDR Report Key: 10722916
• MDR Text Key: 222155796
• Report Number: 3004750704-2020-00050
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474609624
• UDI-Public: (01)05050474609624(17)220831(10)UE31537
• Combination Product (y/n): Y
• Reporter Country Code: HK
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: TH55ML
• Device Catalogue Number: 10270011
• Device Lot Number: UE31537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1