MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	ZXT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Date of Event	03/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight: unknown/not provided.If explanted; give date: not applicable.Lens remains implanted.Device evaluation: product evaluation was not performed because the product remains implanted.The complaint issue reported could not be verified and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.Historical data analysis: a search of complaints revealed one other investigation has been received for this production order number.But the complaint issue reported could not confirmed; therefore, no escalations are required.Conclusion: as a result of the investigation there is no indication of a quality product deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The patient reported that he had the symfony intraocular lenses (iols) implanted in both eyes.Right after surgery, he informed his doctor that the glare and halos are bothering him.He cannot see distant or nearby.He was informed that he will not need to wear glasses after having the lenses in place.However, he now own three pair of glasses.He cannot see the street signs when driving, including driving at night.He could no longer do his daily activities because the brightness (day light) is hard on his eyes.He can no longer go fishing with his wife and cannot do most activities that they once enjoyed.It was stated later on that the doctor performed lasik on the left eye first and the halos went away.Subsequently, lasik procedure was done on the right (od) as well, but the right eye has not improved.He had used eye drops, but it did not help.He does not know the name maybe "visine".The doctor also prescribed a type of steroid, but he does not have the information.He then followed up with two other physicians.They both told him that it could be dangerous to have the lens removed from his right eye.It seemed that the lens allows too much light going through and that may not help with the astigmatism.He went back to his original doctor, dr.Currier and shared with him that he has learned from the other physicians, dr.Currier told him that he can do a lens exchange.The patient is very frustrated that the outcome is not as expected.No further information provided.This report represents the right (od) eye.A separate medwatch will be filed for the left (os) eye.
Additional Manufacturer Narrative
Additional information: new information received that the patient now had the lens extracted from his right eye on monday, (b)(6) 2021.The explanted lens was replaced with a competitor lens, model pcli61a0.The explant went well with no issues; however, post-exchange, the patient is experiencing some itchiness and burning sensation, but nothing major; he attributes this to the healing process.He is no longer seeing halos and is happy with the new lens.The following fields have been updated: section d6b: explant date: (b)(6) 2021.Section h6 health effect - impact code: 4629 - explant.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: return to manufacturer: 2/1/2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed the lens was received stuck to a piece of paper and therefore covered in particles after removal.The lens was cleaned an no defects were observed.No defects related to or could contribute to visual issues were observed.The complaint issue was not confirmed and no product deficiency could be identified.Conclusion: as a result of the investigation, there is no indication of a quality product deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12652797
• Report Number: 2020664-2021-07775
• Device Sequence Number: 11884587
• Product Code: POE
• UDI-Device Identifier: 05050474605206
• UDI-Public: (01)05050474605206(17)240227
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/11/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/27/2024
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2021
• Supplement Date Received by Manufacturer: 12/21/2021; 03/07/2022
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 01/18/2022; 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White