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

Model Number DIB00

Device Problems Break (1069); Delivered as Unsterile Product (1421)

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

Event Date 11/22/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: product testing could not be performed as the product was not returned.The reported event could not be verified, and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that no additional complaints were received for this po.Conclusion: based on the investigation, no product deficiency was identified.Attempts have been made to obtain the missing information.However, to date it has not been received.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

Event Description

It was reported that after opening the intraocular lens (iol) package it was noticed the haptic was bent but not detached.The inner pouch was already opened/unsealed when they received the iol.There was no patient contact with the product.The procedure was completed with a backup johnson and johnson iol of the same model and diopter.No further information was provided.

Manufacturer Narrative

Corrected data: upon further review, it was noted that date of event of 11/22/2022, submitted in the initial report (mfr# 3012236936-2022-02967) was incorrect.Correct date of event is 11/21/2022.This report is being submitted to correct this.Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: dec 21, 2022.Section h3: evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the lens was stuck inside the cartridge/ cartridge tip.Removal of the lens was attempted however the lens could not be removed without further damaging the lens and cartridge.The complaint simplicity was disassembled and inspected under magnification and no assembly issues or issues that could cause or contribute to the compliant issues were identified.A product quality deficiency could not be determined.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.All pertinent information available to johnson & 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: 15974484
• MDR Text Key: 308294924
• Report Number: 3012236936-2022-02967
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474731738
• UDI-Public: (01)05050474731738(17)250820
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• 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: DIB00U0190
• 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: 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2022
• 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
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 44 KG