MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; INTRAOCULAR LENS

Model Number DIB00

Device Problems Break (1069); Failure to Advance (2524)

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

Event Date 09/28/2023

Event Type  malfunction  

Event Description

It was reported that the preloaded intraocular lens (iol) was stuck in the injector during advancement.Through follow up we learned that a damage of the lens could not be ruled out because it was plugged into the shooter.Account indicated that the issue happened before any product contact with the patient.No further information was 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 d6a: if implanted, give date: not applicable, as there was no patient contact with the product.Section d6b: if explanted, give date: not applicable, as there was no patient contact with the product.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 d9 - device available for evaluation? yes section d9 - date returned to manufacturer: 29-nov-2023 section h3 - device evaluated by manufacturer? yes device evaluation: the product was returned to the manufacturing site for evaluation.The suspect handpiece was received with the plunger rod partially advanced and the intraocular lens (iol) stuck in the cartridge.No ophthalmic viscosurgical device (ovd) residue was present.Visual inspection of the iol found no issues, but the lens was unable to be removed from the cartridge for further inspection.No issues that could contribute to the complaint issue were identified.The complaint issue was not identified during photograph and product evaluation.No further evaluation was performed.The complaint issue of lens damaged was not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.The complaint issue of device advancement issue was not identified during photograph and product evaluation.The observed issue of stuck in cartridge is similar to the reported complaint issue.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 SIMPLICITY
• Type of Device: INTRAOCULAR LENS
• 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: 18057513
• MDR Text Key: 327766870
• Report Number: 3012236936-2023-02620
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474655423
• UDI-Public: (01)05050474655423(17)260511
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIB00
• Device Catalogue Number: DIB00I0210
• 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: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2023
• 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