FDA Adverse Event Injury Summary report: N

TECNIS IOL

MDR report key: 14430712 · Received May 18, 2022

Report

Report Number: 3012236936-2022-01303
Event Type: Injury
Date Received: May 18, 2022
Date of Event: April 20, 2022
Report Date: May 17, 2022
Manufacturer: AMO MANUFACTURING NETHERLANDS
Product Code: POE
UDI-DI: 05050474574656
PMA / PMN Number: P980040
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

THE DEVICE IS NOT RETURNING FOR EVALUATION AS TO DATE 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. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) IN PATIENT'S LEFT EYE ROTATED MORE THAN 10 DEGREES FROM INTENDED POSITION. ISSUE OCCURRED DURING POST-OP DAY 1. POSTOPERATIVE 1 DAY VISIT EXAMINATION SHOWS EXPECTED VISUAL ACUITY AND THE PATIENT DIDN¿T FEEL UNCOMFORTABLE. PRE-OP COMMENTS: BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) 0.25, POST-OP COMMENTS: UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) 0.5. HOWEVER, ABOUT 2 WEEKS LATER, IT WAS NOTED THAT A SECONDARY SURGICAL INTERVENTION WAS PERFORMED TO REPOSITION ROTATIONALLY THE IOL. NO FURTHER INFORMATION AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2754782	TECNIS IOL	EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS	POE	AMO MANUFACTURING NETHERLANDS	ZXT225		05050474574656

Patients

Seq	Age	Sex	Outcome	Treatment
1		Female	Required Intervention