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

Model Number DCB00

Device Problems Difficult to Insert (1316); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2023

Event Type  malfunction  

Manufacturer Narrative

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, 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the doctor inserted a monofocal intraocular lens (iol) into a patient¿s operative eye and it was then determined that it was not a good fit.The lens was removed, and the doctor went with an alternate.It was indicated that the lens is not returning.No further information was provided.

Manufacturer Narrative

Additional information: additional information received from customer clarified that the intraocular lens (iol) did not have patient contact after all.The package was opened but the lens was never implanted and remained on the table.The patient in this case had to have a vitrectomy and required a 3-piece lens.The customer indicated that the lens was not defective; however, it was disposed of due to having been opened.Corrected data: based on the additional information received form the account which indicated that there was no patient contact with the device, that the lens was never implanted/was not defective and as there is no allegation against the iol; therefore, the event no longer meets the reportable criteria and no further information will be provided under this manufacturer report number 3012236936-2023-02585.The following field was updated accordingly: section a2, a4 and a5: not applicable, as there was no patient contact with the device.Section d6a: if implanted, give date: not applicable, no patient contact with the device.Section d6b: if explanted, give date: not applicable, no patient contact with the device.Section h6: health effect - impact code: 2199 - no health consequences or impact section h6: medical device problem code: 2993 - adverse event without identified device or use problem the following codes entered in initial mdr report no longer apply: section h6: health effect - impact code: 4631 - more complex surgery; section h6: medical device problem code: 1316 - difficult to insert.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

• Brand Name: TECNIS SIMPLICITY
• 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: 17908374
• MDR Text Key: 325929994
• Report Number: 3012236936-2023-02585
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474636187
• UDI-Public: (01)05050474636187(17)260321
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 10/17/2023
• Supplement Dates FDA Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2023
• 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