MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number DFW150

Device Problems Break (1069); Difficult to Fold, Unfold or Collapse (1254); Ejection Problem (4009)

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

Event Date 06/28/2023

Event Type  malfunction  

Event Description

It was reported that the intraocular lens (iol) had been released with its trailing haptic stretched and its haptic had been damaged when implanted.The lens was removed after being partially implanted with its optical part.The reporting physician had not had a feeling of resistance when it was implanted and the setting was conducted as per the instructions as usual.There was no patient injury and no further information was provided.

Manufacturer Narrative

Section a2, a4 and a5: unknown, as information was requested but not provided.Section d6a - implant date: implant date does not apply because the lens was removed during the same procedure.Section d6b - explant date: explant date does not apply because the lens was removed during the same procedure and has never been implanted.Section e1 - telephone number:(b)(6).Section h3 - other (81): the intraocular lens (iol) was not returned for evaluation.Therefore, a failure analysis of the complaint device could not 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 and possible product return and evaluation, 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 and johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional information: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: jul 18, 2023.Section h3 - device evaluated by manufacturer? yes.Device evaluation: visual inspection under magnification revealed that the complaint handpiece was received with the plunger rod fully advanced and with a detached haptic stuck in the cartridge as well as overridden by the plunger rod.Inspection of the cartridge and lens module revealed that the handpiece was received with viscoelastic residue dispersed throughout the cartridge, suggesting that an adequate amount of ovd (ophthalmic viscoelastic device) was used.The handpiece was disassembled and the assembly was inspected, no issues that could cause or contribute to the complaint issue could be identified.The detached haptic was removed from the cartridge and the entire lens was cleaned, revealing that the lens was cut in half and that both haptics were detached (one missing).The complaint issue of haptic detached was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.The complaint issues of delivery issue and trailing haptic not folded were not confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Type of Device: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 17386419
• MDR Text Key: 319897575
• Report Number: 3012236936-2023-01730
• Device Sequence Number: 1
• Product Code: MFK
• UDI-Device Identifier: 05050474711075
• UDI-Public: (01)05050474711075(17)240204
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P980040
• 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,Followup
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2024
• Device Model Number: DFW150
• Device Catalogue Number: DFW150I210
• 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: 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2021
• 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