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

Model Number DCB00

Device Problem Scratched Material (3020)

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

Event Date 02/14/2024

Event Type  malfunction  

Event Description

It was reported that a preloaded monofocal intraocular lens (iol) has a lens scratch in the middle, so the surgeon took out and removed the lens and replaced it with a new one.Through follow up, the customer reported no other information is available.No further information was provided.

Manufacturer Narrative

Section a2, a4, a5: unknown/asked but unavailable (asku).Section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section e1: telephone number: (b)(6).Section h3-other (81): the device was not returned for evaluation; 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.Attempts have been made to obtain missing information.However, to date, there is no additional information available.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: 18851986
• MDR Text Key: 337304117
• Report Number: 3012236936-2024-00583
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474636071
• UDI-Public: (01)05050474636071(17)260811
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000195
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2023
• 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