MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. EMERALD; SURGICAL ADJUNCTS

Model Number EMERALDC30

Device Problem Contamination (1120)

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

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.Date of event: unknown, not provided.If implanted; give date: n/a (not applicable).The cartridge is not an implantable device.If explanted; give date: n/a (not applicable).The cartridge is not an implantable device.Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a customer is returning the za9003 intraocular lens (iol) and emerald cartridge due to a complaint of a "film" on the za9003.It was stated that the customer is not sure if the film is on the lens or if it came from the cartridge.It was learned that the iol remains implanted.No other information was provided.This mdr report pertains to the cartridge suspect product.A separate report will be submitted for the iol suspect product.

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:(b)(4).

Manufacturer Narrative

Corrected data: upon further review of the suspect cartridge initial mdr submission, it was noted that section h3 (reason for non-evaluation) was inadvertently entered.In initial mdr section:h3 what was chosen was "other: 81".What should have been chosen was ¿device evaluation anticipated, but not yet begun (02)¿.This supplemental report is being submitted to indicate correction of information.Evaluation of product return is noted below.Additional information: section d10.Device available for evaluation? yes.Returned to manufacturer on: 4/3/2020.Section h3.Device returned to manufacturer? yes.Device evaluation: visual inspection using microscope magnification was performed: no physical damage or foreign material were observed on the samples.However, the sample was evaluated with sme (subject matter expert) to address the complaint issue reported and a representative sample was sent to a 3rd party lab for analysis.The reported issue was not verified and based on the product returned evaluation a product quality deficiency or product malfunction could not be determined.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed 6 other complaint folders have been created for this production order number.On all files it was learned that products met manufacturing release criteria.Conclusion: 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.

• Brand Name: EMERALD
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9881709
• MDR Text Key: 185013783
• Report Number: 2648035-2020-00281
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)200129(10)CE01194
• Combination Product (y/n): Y
• PMA/PMN Number: K961242
• 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: 01/01/2005,10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2020
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CE01194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2020
• 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
• Treatment: ZA9003 LENS SN: (B)(4).; ZA9003 LENS SN: (B)(4)