MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. UNFOLDER PLATINUM 1 SERIES; LENS, GUIDE, INTRAOCULAR

Model Number 1MTEC30

Device Problem Crack (1135)

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

Event Date 06/21/2022

Event Type  malfunction  

Manufacturer Narrative

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.Initial reporter telephone number: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that there was a bend at the cartridge tip while trying to insert the intraocular lens (iol).Account indicated that the cartridge tip was in contact with the eye.No further information is available.This is report 2 of 2 as the customer reported a total of two cartridges with the same issue.A separate report is being submitted for each of the cartridges.

• Brand Name: UNFOLDER PLATINUM 1 SERIES
• 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: 15055994
• MDR Text Key: 301928302
• Report Number: 3012236936-2022-01916
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)230304(10)CK07350
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2023
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CK07350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• 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