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

Model Number DFR00V

Device Problem Break (1069)

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

Event Date 01/18/2024

Event Type  malfunction  

Event Description

It was reported that the optic was found to be defective after implantation.Through follow-up, we learned that the patient is doing well so far.The visual acuity without correction is 0.8, and as of now, there are no plans for explanting the intraocular lens (iol).No further details provided.

Manufacturer Narrative

Section a2, a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d6b: explant date: not applicable, lens remains 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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional information: section h3 - device evaluated by manufacturer? yes.Section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: 28-mar-2024.Device evaluation: product evaluation was performed on the picture provided by the customer.The picture displayed a lens with two triangle shaped crack like marks on the lens.The root cause and potential clinical impact of the reported event cannot be determined from a picture assessment.The product was returned to the manufacturing site for evaluation.The complaint device presented with stress marks on the cartridge/cartridge tip that were in specification for a used device.The cartridge tip was also observed to be slightly deformed.Viscoelastic residue was evenly distributed indicating an adequate amount was used.The plunger rod was inspected and no issues were identified.No lens was received for evaluation.The complaint issue of "lens damaged" 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.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: 18691975
• MDR Text Key: 335408398
• Report Number: 3012236936-2024-00251
• Device Sequence Number: 1
• Product Code: MFK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VI185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2022
• 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