MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. EMERALD CARTRIDGE LENS, GUIDE, INTRAOCULAR

Model Number EMERALDC30

Device Problems Material Fragmentation (1261); Device Difficult to Setup or Prepare (1487); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2021

Event Type  malfunction  

Manufacturer Narrative

Pt info: unknown/ not provided. If implanted, give date: not applicable, the cartridge is not an implantable device. If explanted, give date: not applicable, the cartridge is not an implantable device. Telephone number: (b)(6). All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

Event Description

Customer reported that during the handling of the emerald cartridge, inserting methylcellulose and position the intraocular lens (iol), the cartridge was presenting rigidity while the iol was being inserted in the eye. Resulting in a torn optical part and the haptic was completely amputated. There was no reported patient impact. No additional information provided.

• Brand Name: EMERALD CARTRIDGE
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; road 402 north, anasco ind. pk; anasco, PR 00610 ; 7142478552
• MDR Report Key: 12200785
• MDR Text Key: 262699222
• Report Number: 2648035-2021-08182
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)220301(10)CJ15429
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/01/2022
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CJ15429
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/21/2021 Patient Sequence Number: 1

Treatment

IOL SERIAL# AND MODEL UNKNOWN