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

Model Number DCB00V

Device Problem Material Fragmentation (1261)

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

Event Date 11/15/2022

Event Type  malfunction  

Manufacturer Narrative

If implanted/explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Initial reporter telephone number: (b)(6).This report is being filed on an international device; tecnis 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 p980040.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 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.

Event Description

It was reported that the intraocular lens (iol) was removed and replaced in the same procedure due to a torn trailing haptic.The torn haptic was identified after insertion into the eye.There was no resistance noticed by the surgeon when preparing or inserting the iol.There was no reported patient injury.

Manufacturer Narrative

Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: jan 19, 2023.Section h3: device evaluated by manufacturer¿ yes.Device evaluation: the complaint lens was received partially in opened non-j&j pouches and another piece of the lens was received stuck in the cartridge of the complaint handpiece.Visual inspection under magnification revealed that part of the lens was received cut and another part of the lens was received stuck in the cartridge of the handpiece with a detached haptic in which the detached haptic was also observed to be damaged (bent) inside the cartridge.The lens was cleaned (no additional cosmetic defects observed) and the intact haptic's width and thickness were measured and measured within specification.The cartridge tip was observed to be returned damaged (flattened tip consistent with drops and shipping damage) and plunger rod tip damage (bent).No additional defects were observed before and after disassembly.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: 15947060
• MDR Text Key: 307947075
• Report Number: 3012236936-2022-03005
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474636620
• UDI-Public: (01)05050474636620(17)250530
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• 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: DCB00V0175
• 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: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2022
• 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: 78 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian