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

Model Number DCB00V

Device Problems Material Fragmentation (1261); Physical Resistance/Sticking (4012)

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

Event Date 02/08/2023

Event Type  malfunction  

Event Description

It was reported that while inserting the intraocular lens (iol) the lead haptic was found to be torn off and attached to the optic.The iol was removed from the eye with tweezers.Another iol was inserted successfully.There was no reported patient injury.No additional information was provided.

Manufacturer Narrative

Telephone number: (b)(6).This report is being filed on an international device; tecnis optiblue 1-piece iol with tecnis simplicity, model dcb00v that has a similar device, tecnis 1-piece iol with tecnis simplicity model dcb00 which is distributed in the unites states under pma (b)(4).Intraocular lens (iol) was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the photo/video device history record, complaint trending, and risk documentation, if applicable 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 were made to obtain the missing information; however, no response has been received.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: returned to manufacturer on: mar 8, 2023.Section h3: device evaluated by manufacturer¿ yes.Device evaluation: the complaint lens was received stuck to a piece of gauze.Visual inspection under magnification revealed that the lens was received cut and torn with a detached haptic that was stuck to the optic.The lens was cleaned and no additional defects were observed.Dimensional inspection of the haptic width and haptic thickness of the intact haptic was performed and measured within specifications.Plunger rod issues (bent plunger rod tip) was observed.No additional defects or assembly issues with the handpiece were observed before and after disassembly.Trace amounts of viscoelastic residue was observed inside the handpiece cartridge which suggests inadequate ophthalmic viscosurgical device (ovd) usage during loading and insertion.The video provided by the customer was reviewed and the complaint lens was observed to be inserted into the eye with the haptic observed to be detached upon insertion.As a result of the investigation 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 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: 16472476
• MDR Text Key: 310949320
• Report Number: 3012236936-2023-00542
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474636651
• UDI-Public: (01)05050474636651(17)240623
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DCB00V
• Device Catalogue Number: DCB00V0190
• 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: 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2021
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian