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

Model Number ZCT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Flashers (1864)

Event Type  Injury  

Event Description

It was reported that a doctor who has implanted over a thousand of tecnis intraocular lenses (iol) has noticed that the reported incidence of positive dysphotopsia immediately post operatively is much higher with the tecnis iol than other competitor lenses that do not have the optic gunnel.Account indicated that patients' daily activities were significantly affected.Doctor expressed dissatisfaction with the tecnis lens design and indicated that it could be due to the optic gunnel which is the non refractive optic edge, a feature of tecnis constant center thickness design.Doctor suggested to reduce the gunnel size.There was no medical or surgical intervention reported.No further information was provided.

Manufacturer Narrative

Pt info: unknown/ not provided.Date of event: unknown, not provided.Catalog number: partial catalog number indicated since the serial number was not provided.Serial number: unknown, information not provided.Expiration date: unknown, as the serial number was not provided.Udi number: a complete udi number is unknown, as the serial number was not provided.Implant date: unknown, information not provided.Explant date: not applicable, there is no indication the device was explanted.(b)(6).Device manufacture date: unknown as the serial number of the device was not provided.(b)(4).Device evaluation: the product testing could not be performed as the product was not returned (the lens remains implanted).The reported complaint cannot be confirmed.Manufacturing record evaluation: the manufacturing record review could not be performed because the serial number of the complaint product is unknown.Since the serial number is unknown, the complaint history review could not be performed.Conclusion: since the sample of the complaint product was not returned, and serial number is unknown, it is not possible to determine a malfunction and/or product quality deficiency.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.

• Brand Name: TECNIS IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 13115733
• MDR Text Key: 284124162
• Report Number: 3012236936-2021-00342
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ZCT
• Device Catalogue Number: ZCT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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