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

Model Number EMERALDC30

Device Problem Failure to Eject (4010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2019

Event Type  malfunction  

Manufacturer Narrative

Lot number: unknown/not provided.Catalog number: only a partial catalog number is known as the lot number was not provided.Expiration date: unknown, as the lot number was not provided.Udi number: only a partial udi# is known as the lot number was not provided.If implanted; if explanted; give date: n/a (not applicable).The cartridge is not an implantable device.Device manufacture date: unknown, as the lot number was not provided.An attempt has 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 initially reported that a za9003 intraocular lens (iol) would not go into the patient¿s right eye.Through follow-up it was learned the lens did have physical contact with the patient, but was not implanted because it would not go in.There was no vitrectomy or suture required.No patient injury.The procedure was completed using a non-johnson and johnson lens.No other information was provided.

Manufacturer Narrative

Device available for evaluation? yes, returned to manufacturer on: 10/18/2019.Device returned to manufacturer? yes.Device evaluation: cartridge was received and lens stuck at the cartridge tube can be observed.Lubricant material residue was not observed in the cartridge.The tip of cartridge was damaged/deformed.The reported issue of stuck in cartridge was verified.The lens partially delivered reported was not verified; however, due to the condition in which the sample was received, it was not possible to determine that the reported issues were related to the manufacturing process.Based on the analysis of the returned product, a product quality deficiency could not be determined.Manufacturing record review: the manufacturing record review could not be performed because the lot number of the complaint product is unknown.However, the controls for the emeraldc30 (emerald cartridge-thermoformed tr, 30 bx) models manufacturing process were checked.The complaint occurrences per lot/batch review could not be performed because the lot number of the complaint product 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.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: 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: 9258720
• MDR Text Key: 165234434
• Report Number: 2648035-2019-01160
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(10)UNKNOWN
• 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: 01/01/2005,11/09/2020

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• 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)
• Patient Age: 74 YR