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

Model Number DIU150

Device Problems Crack (1135); Mechanical Problem (1384)

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

Event Date 03/31/2022

Event Type  malfunction  

Event Description

It was reported that the inserter plunger of the preloaded device was off to the side of optic rather than being behind the haptic of the intraocular lens and so did not push out correctly causing the tip to crack due to the extra bulk of plunger to the side of optic.As this was the second lens being used on the patient, the doctor tried a couple times to move the plunger behind the lens and after a couple try¿s was able to get the plunger to realign with the back of the lens and he was able to insert the lens into the right eye.Additional information received revealed that the surgeon watched the load going to side under the microscope and not when inside patient's right eye and confirmed that the tip of the cartridge was not cracked.It was assessed that the injector did not function as expected causing the lens to bundle up and cracking the cartridge.The lens remains implanted.There was no patient injury and no other intervention was required.The patient was doing fine post operation.No further information was provided.

Manufacturer Narrative

Patient weight: unknown, asked but not available.Ethnicity/race: unknown, asked but not available.If explanted, give date: not applicable, the lens remains implanted in the eye.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification revealed that the handpiece was received with the plunger rod fully advanced.Investigation of the external assembly revealed that the plunger rod tip was bent.Furthermore, the cartridge tip and cartridge were observed to be damaged.The handpiece was disassembled and the assembly was inspected; no assembly issues were identified.No iol was received as part of this return therefore, no product evaluation could be performed on the lens.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.The search revealed two additional investigation request (ir) for this production order number has been received, however, the issues could not be confirmed as related to manufacturing although the complaint issues were related; therefore, no escalations are required.Conclusion: the observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.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: 15048673
• MDR Text Key: 304708291
• Report Number: 3012236936-2022-01837
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 05050474746770
• UDI-Public: (01)05050474746770(17)240628
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIU150
• Device Catalogue Number: DIU150U315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2021
• 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: Female
• Patient Race: White