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

Model Number DIB00

Device Problem Inaccurate Delivery (2339)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/17/2023

Event Type  malfunction  

Event Description

It was reported during implantation, the doctor realized the pre-loaded dib00 model intraocular lens (iol) did not appear.Then in a second attempt, half came out towards the eye and the other remained inside the plunger or injector.The doctor had to explant that half of the lens and place another iol, that he had in reserve for the second eye, into the patient¿s ocular dexter (right eye).The incision was increased from 2.4 to 3 mm when you tear the lens and one has to remove the half that entered the anterior chamber; thus indicating the doctor tore the iol.Surgery on the patient's other eye is pending.Through follow-up, additional information was received confirming the back-up lens that was implanted was a dib00 19.5 diopter iol.Patient outcome post-procedure was reported as right eye surgery av 2/40 refraction -0.50 cyl -0.50x58 grades without complications.Left eye surgery was performed (b)(6) 2023 without complications.No further information is available.

Manufacturer Narrative

Additional information: sections a-4 patient weight and a-5 patient race: unknown/asked information unavailable.Section d-6a date implanted: not applicable as the iol was not implanted.Section d-6b date explanted: not applicable as the iol was not implanted, therefore not explanted.Section e-1 telephone number: (b)(6).Section h3-81: 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.Section h-6 health effect - impact code: 4625 incision enlargement.Section h-6 health effect - clinical code: 4581 incision enlargement.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: 17094103
• MDR Text Key: 317442350
• Report Number: 3012236936-2023-01439
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474655386
• UDI-Public: (01)05050474655386(17)251108
• Combination Product (y/n): N
• Reporter Country Code: VE
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIB00
• Device Catalogue Number: DIB00I0190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2022
• 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 Sex: Male
• Patient Ethnicity: Hispanic