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

Model Number DCB00V

Device Problems Material Fragmentation (1261); Mechanical Problem (1384); Device Difficult to Setup or Prepare (1487)

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

Event Date 07/26/2022

Event Type  malfunction  

Manufacturer Narrative

Not applicable as there was no patient involvement.If implanted, give date: not applicable, as lens was not implanted if explanted, give date: not applicable, as lens was not implanted, hence not removed.Email address: unknown/not provided.Telephone number: (b)(6).The device is not returned; therefore, a failure analysis of the complaint device cannot be completed.A review of the device record and complaint trending 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, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that when turning the plunger of an iol, the reporting physician got a resistance feeling and found its haptic got detached in the cartridge because the plunger rod could not grip the lens in its cartridge.There was no patient contact as the issue was prior to use.There was no patient injury.No other information was provided.

Manufacturer Narrative

Additional information: section d9: device available for evaluation?: yes.Section d9: returned to manufacturer: yes.Section d9: date returned to manufacturer: aug 17, 2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received stuck to the handpiece tray with a detached haptic stuck inside the handpiece cartridge.The original complaint handpiece, folding carton, patient identification (id) card, implant notification card, patient stickers, and direction for use (dfu) were received as well.Visual inspection under magnification after cleaning revealed that the complaint lens was returned with a detached haptic and lens damage on the optic body.A detached haptic was observed stuck in the damaged cartridge and cartridge tip.No additional defects or assembly issues was observed with the handpiece before and after disassembly.Viscoelastic residue was observed inside the lens module.The complaint issue "haptic detached" was identified during product evaluation (difficult to use and override" could not be confirmed; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.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 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: 15254964
• MDR Text Key: 305183078
• Report Number: 3012236936-2022-02202
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474636729
• UDI-Public: (01)05050474636729(17)241007
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: DCB00V0225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/28/2022
• Initial Date FDA Received: 08/18/2022
• Supplement Dates Manufacturer Received: 09/15/2022
• Supplement Dates FDA Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2021
• 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