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

Model Number EMERALDC30

Device Problems Contamination (1120); Crack (1135)

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

Event Date 12/07/2021

Event Type  malfunction  

Event Description

It was reported that the cartridge cracked and debris was found in the eye. It was removed and no impact or adverse event to patient. No further information was available.

Manufacturer Narrative

(b)(6). It was indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device cannot be completed. A review of the device history record, complaint trending, and risk documentation for this device will be performed. Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed. Attempts have been made to obtain missing information; however, to date, no response has been received. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.

• Brand Name: UNK_CARTRIDGE_EMERALD
• 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 ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 13177297
• MDR Text Key: 290376670
• Report Number: 3012236936-2022-00056
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/04/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No