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	Flashers (1864); Visual Disturbances (2140)
Date of Event	12/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Telephone number: (b)(6).An attempt has 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 or Problem Description
It was reported that an intraocular lens (iol) was explanted from a patient¿s left eye due to symptoms of glare at night and starburst which were disabling to the patient.The symptoms started about 1-week post-op.The patient waited one-month post operation trying to adapt and see if the glare/starbursts improved to tolerable level.The patient is happy with the distance and near vison, but the night glare/starbursts were disabling; therefore, the patient elected to have an iol exchange.The patient is happy with the distance only on the other eye with monofocal toric lens.It was noted that the issues were observed during post-op examination.There was no vitrectomy performed, and no incision enlargement or sutures required.No delay in the procedure was reported.The patient has a prior history of radial keratotomy (r.K.) surgery in1990's.No further information was provided.Visual acuity pre-op: 20/30.Visual acuity post-op: 20/25 distance/j3 near.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes; returned to manufacturer on: (b)(6) 2021.Section h3: device evaluated by manufacturer? yes.Device evaluation: the lens was received at the manufacturing site for evaluation.The lens was cleaned and visual inspection under magnification revealed that the lens was received cut in half, which is consistent with a lens that was handled during explant.Manufacturing records review: the manufacturing process record was evaluated, and no deviation was found during process related to the complaint issue reported.The product was manufactured and released according to specifications.A search in complaint system revealed that two additional complaints were received for this production order number; however, no product quality deficiency was identified on either of the cases.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.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 9728 NX; NL 9728 NX
• MDR Report Key: 11319971
• Report Number: 9614546-2021-07066
• Device Sequence Number: 3283943
• Product Code: POE
• UDI-Device Identifier: 05050474605251
• UDI-Public: (01)05050474605251(17)231206
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2021

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: 12/06/2023
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 03/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention