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

Model Number EMERALDC30

Device Problems Material Fragmentation (1261); Device Difficult to Setup or Prepare (1487); Use of Device Problem (1670)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Event Description

It was reported that an intraocular lens (iol) was taken out of the patient's operative eye after implantation as the trailing haptic had been detached and remained in the cartridge.A different lens was to be implanted within days.There was no patient injury reported.Account provided that it was likely that the doctor improperly loaded the lens into the cartridge.The account also indicated that the detached haptic issue was caused by the cartridge as the lens did not fit into the cartridge as expected.Account mentioned that loading the lens would be made easier if the cartridge was transparent.No further information was provided.

Manufacturer Narrative

Date of event: unknown/no information.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; therefore, not explanted.Phone number: (b)(6).Email address: unknown/no information.(b)(4).The device is not returning for evaluation as it was discarded; 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 12849019
• MDR Text Key: 282195640
• Report Number: 3012236936-2021-00069
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)220309(10)CJ16469
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2022
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CJ16469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2021
• 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
• Treatment: INTRAOCULAR LENS, SN UNKNOWN