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

Model Number DCB00V

Device Problem Contamination (1120)

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

Event Date 11/29/2022

Event Type  malfunction  

Manufacturer Narrative

Explant date: if explanted; give date: n/a (not applicable).The lens remains implanted.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 as it remains implanted; 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 a glittering substance was found attached to the backside of the intraocular lens (iol) after implantation.There was no reported patient injury, no postoperative inflammation and the patient's visual acuity has improved to 1.2 since the day after the operation.The iol remains implanted and no intervention is planned.No additional information was provided.

Manufacturer Narrative

Additional information: device evaluation: no complaint product was received for evaluation.A customer provided photo was received for evaluation.The customer provided photo was reviewed by sme, it shows a pseudophakic eye at the final implantation stage (irrigation aspiration) of a lens claimed to be a tecnis monofocal with optiblue 1-piece iol with simplicity model dcb00v.Few (4-6) scattering points at the optic-haptic junction can be observed; however, due to the image quality we cannot observe specific details.Regarding next step recommendation, we are not in a position to provide advice from a picture assessment; it is usually recommended for the surgeon to follow its clinical expertise on next steps based on the perceived level of patient risk through clinical follow up.The root cause of the reported event as well as its potential clinical impact cannot be determined from a picture assessment.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: 16044730
• MDR Text Key: 308170061
• Report Number: 3012236936-2022-03184
• Device Sequence Number: 1
• Product Code: HQL
• 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: 03/15/2023

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: DCB00V0195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/23/2022
• Supplement Dates Manufacturer Received: 02/27/2023
• Supplement Dates FDA Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• 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 Ethnicity: Non Hispanic
• Patient Race: Asian