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

Model Number DIB00

Device Problems Break (1069); Mechanical Problem (1384); Misassembled (1398); Failure to Align (2522)

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

Event Date 06/01/2022

Event Type  malfunction  

Manufacturer Narrative

Age, weight, ethnicity: unknown/ asked but not available.Catalog number: a complete catalog number is unknown, as the serial number was not provided.Serial number: unknown, information not provided.Expiration date: unknown, as serial number was not provided.Unique device identifier (udi #): unknown, as serial number was not provided.If implanted, give date: not applicable, as there is no indication that the lens was implanted.If explanted, give date: not applicable, as there is no indication that the lens was implanted.The device was not returned for analysis.Therefore, a failure analysis of the complaint device cannot 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, if there is any further relevant information a supplemental medwatch will be filed.Device manufacture date: unknown as serial number was not provided.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the preloaded device had loading issue that it started crunching when it was turned and seemed like misaligned.There was no patient contact and the event was observed during handling.No other information was provided.

Manufacturer Narrative

Additional information: section b5: additional information received from the surgical facility revealed that there was no damage to the actual lens.The issue was that the lens guide was not properly and set did not lift the lens carrier.Once the lens was pushed forward, it did not engage with the cartridge.Corrected data: therefore, the current report captures the following correction: section d4: catalog number: dib00u0095.Section d4: serial number: (b)(6).Section d4: expiration date: jan 11, 2024 section d4: unique device identifier (udi #): (b)(4).Section h4: device manufacture date: jan 11, 2021.Section h6: medical device problem code: 2522 - failure to align.Section h6: medical device problem code: 1384 - mechanical problem.Additional information received confirmed that there was no damage to the actual lens; therefore, this report is no longer a reportable event and no further information will be provided under mfr report number 3012236936-2022-01703.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: 14849489
• MDR Text Key: 302777370
• Report Number: 3012236936-2022-01703
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474731547
• UDI-Public: (01)05050474731547(17)240111
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2024
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0095
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• 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