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)

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

Event Date 06/21/2023

Event Type  malfunction  

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.

Event Description

It was reported that during implantation of the intraocular lens (iol), the trailing haptic had unfolded, and when it had been pushed without changes, it got damaged.The reporting physician noticed that the trailing haptic stretched after the iol was implanted into the patient¿s eye, and decided to continue implantation without any change.It then was found that the haptic had been damaged and the lens was removed.Setting was conducted as usual and the resistance at the time of implantation was normal.There was no patient injury and no further information was provided.

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 advanced to the cartridge tip.A detached haptic could be observed to be stuck inside of the cartridge and overridden by the plunger rod.No additional defects or assembly issues were observed before and after disassembling the handpiece.Viscoelastic residue was observed inside the lens module area.The lens was removed from the cartridge revealing a cut and a detached haptic.Dimensional inspection was performed on the intact haptic and haptic thickness measured within specification; however, due to return condition haptic width could not be measured.In response to the special request, the returned complaint product was evaluated and trace amounts of viscoelastic residue was observed inside the lens module suggesting excess ovd (ophthalmic viscoelastic device) was used during loading and insertion which may have contributed to the reported complaint issue.Ovd inside the lens module area may displace the lens from its intended position which may result in the plunger rod engaging incorrectly with the lens during plunger rod advancement during insertion.The risk assessment documents were reviewed as well.The complaint issue of haptic damaged was not confirmed; however, the observed haptic detached is similar to the reported complaint issue.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.

Manufacturer Narrative

Additional information: through follow-up the serial number of the suspect lens was corrected: (b)(4).Section d4 - serial#: (b)(6).Section d4 - expiration date: 3rd november 2023.Section d4 - udi #: (b)(4).Section h4 - device manufacture date: 3rd november 2020.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: 17386398
• MDR Text Key: 320302478
• Report Number: 3012236936-2023-01731
• Device Sequence Number: 1
• Product Code: MFK
• UDI-Device Identifier: 05050474711020
• UDI-Public: (01)05050474711020(17)231103
• 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,Followup
• Report Date: 09/27/2023

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: 11/03/2023
• Device Model Number: DFW150
• Device Catalogue Number: DFW150I185
• 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: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2020
• 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