FDA Adverse Event Injury Summary report: N

TECNIS IOL

MDR report key: 17873853 · Received October 4, 2023

Report

Report Number: 3012236936-2023-02405
Event Type: Injury
Date Received: October 4, 2023
Report Date: October 4, 2023
Manufacturer: AMO PUERTO RICO MFG. INC.
Product Code: HQL
UDI-DI: 05050474531697
PMA / PMN Number: P980040
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

ADDITIONAL INFORMATION: SECTION B3: DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE DATE IS BETWEEN 5/12/2023 AND 09/12/2023. SECTION D6A: IF IMPLANTED; GIVE DATE: UNKNOWN/ ASKED BUT NOT AVAILABLE. SECTION D6B: IF EXPLANTED; GIVE DATE: UNKNOWN/ ASKED BUT NOT AVAILABLE. SECTION H3-OTHER (81): 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 AND COMPLAINT HISTORY FOR PRODUCTION ORDER 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.

Description of Event or Problem · 0

IT WAS REPORTED THAT A SINGLE-PIECE MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO AN UNKNOWN REGAIN. OTHER PATIENT INJURIES, INTERVENTIONS AND OUTCOMES WAS UNKNOWN. NO OTHER INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2277997	TECNIS IOL	INTRAOCULAR LENS	HQL	AMO PUERTO RICO MFG. INC.	ZCB00		05050474531697

Patients

Seq	Age	Sex	Outcome	Treatment
1		Male	Required Intervention