MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number DIU100

Device Problems Break (1069); Mechanical Problem (1384)

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

Event Date 10/24/2022

Event Type  malfunction  

Event Description

It was reported that after application of the ovd (ophthalmic viscoelastic device) into the port, the plunger went under the intraocular lens (iol).Fortunately, the surgeon noticed it and tried to get the lens out of the simplicity delivery system.This occurred outside the patient´s eye and there was no patient contact.The lens was damaged and could not be implanted.Through follow-up, it was learned that the surgeon followed the directions for use (dfu) and implanted a new unit of the same type of lens.No further information was provided.

Manufacturer Narrative

Age, weight, ethnicity: not applicable, as there was no patient involvement.If implanted, give date: not applicable, as there was no patient involvement.If explanted, give date: not applicable, as there was no patient involvement.Telephone number: (b)(6).Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.A search of complaints related to this production order (po) was performed.The search of complaints revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.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-2022.Section h3.Device evaluated by manufacturer? yes.Device evaluation: the product was returned to the manufacturing site for evaluation.The complaint device was received inside of the original folding carton, including patient stickers, a blank implant notification card, and the directions for use (dfu).Visual inspection under magnification revealed that the complaint device was received with the lens haptic stuck inside of the cartridge tip.The plunger rod could also be observed to be overriding the lens haptic.The device assembly was inspected and no issues that could contribute to or cause the observed issues were identified.The lens was removed from the cartridge and cleaned, revealing that the lens was damaged.The complaint issue of lens damaged and override were 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 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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 15820877
• MDR Text Key: 307804560
• Report Number: 3012236936-2022-02744
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 05050474725881
• UDI-Public: (01)05050474725881(17)250904
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIU100
• Device Catalogue Number: DIU100I225
• 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: 10/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2022
• 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