MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. SENSAR IOL; INTRAOCULAR LENS

Model Number AR40E

Device Problem Material Fragmentation (1261)

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

Event Date 10/10/2022

Event Type  malfunction  

Event Description

It was reported that there are two techno vigilance notifications.In both cases, the supplier collects the materials and sends them to the manufacturer for analysis, after the analysis we receive the feedback.If it is found that there really was a manufacturing defect, the supplier sends a return note referring to the supplies, generating a credit for the hospital, "lens with absence of a handle".Surgeon was unable to implant the lens that had a manufacturing defect, the lens box and lens were kept together with the case for later analysis.No other information was provided.This report captures event for suspect product ar40e, serial number: (b)(4).The other suspect product mentioned will be captured in a separate report.

Manufacturer Narrative

Implant date: if implanted, give date: unknown/not provided.Explant date: if explanted, give date: unknown/not provided.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data as per additional information: the detached haptic did not have any contact with the patient.Upon further review of the file, it was noted that this event is no longer reportable as the account provided there was no patient contact with the device.Therefore, this supplemental filing is to state that this event is not reportable per additional information received and no further information will be submitted under this mfr report.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: SENSAR IOL
• 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: 15954962
• MDR Text Key: 308045066
• Report Number: 3012236936-2022-03066
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474502079
• UDI-Public: (01)05050474502079(17)260916
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2021
• 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