MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS UNK_TECNIS TORIC IOL; INTRAOCULAR LENS

Model Number UNKNOWN

Device Problem Unstable (1667)

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

Event Type  Injury  

Manufacturer Narrative

Age or date of birth, weight, ethnicity: information unknown/not provided.Date of event: the exact date is unknown, the best estimate is on or prior to the reporting date of (b)(6) 2021.Expiration date: unknown as the serial number was not provided.Serial number: unknown/not provided.Model number: unknown as the serial number was not provided.Catalog number: the catalog number is unknown as product serial number was not provided.Unique identifier (udi) number: the udi number is unknown, as product serial number was not provided.Implant date: unknown, information not provided.If explanted, give date: not applicable as the device remains implanted.Device manufacture date: unknown as the serial number was not provided.The device was not returned for analysis as it remains implanted.The serial number for this device is not available; therefore, no further investigation can be performed.If there is any further relevant information received, 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 the doctor intended to exchange an intraocular lens (iol) that had rotated in a patient, but realized during the surgery that he was able to correct the rotation.No further information was provided as to if the lens that had rotated was a johnson and johnson lens or not.No further information was provided.

• Brand Name: UNK_TECNIS TORIC IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 13198265
• MDR Text Key: 288359919
• Report Number: 3012236936-2022-00089
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNK-TECNIS TORIC IOL-UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention