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

Model Number DFR00V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Flashers (1864); Blurred Vision (2137)

Event Type  Injury  

Manufacturer Narrative

Age or date of birth, weight and ethnicity: unknown/no information date of event: the exact date is unknown, the best estimate is between 23 feb 2022 and 18 may 2022.Device evaluated by mfr: 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, 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 have been made to obtain the 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 intraocular lens (iol) was explanted from the patient's operative eye due to experiencing blurry vision and star bursts at night.There was no patient injury reported.Account indicated that the patient's visual acuity 2 weeks post surgery was 20/25.The patient was reportedly doing good and can read with over the counter readers.The explanted iol is not available to be returned for evaluation.No further information was provided.

• Brand Name: TECNIS 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: 14691794
• MDR Text Key: 294273231
• Report Number: 3012236936-2022-01494
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474750531
• UDI-Public: (01)05050474750531(17)240912
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male