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

Model Number DIU150

Device Problems Break (1069); Crack (1135); Mechanical Problem (1384); Inaccurate Delivery (2339); Mechanical Jam (2983)

Patient Problems Eye Injury (1845); Blurred Vision (2137); Capsular Bag Tear (2639)

Event Date 12/21/2022

Event Type  malfunction  

Manufacturer Narrative

Weight, ethnicity: unknown/not provided.Patient information cannot be provided due to personal data privacy legislation/policy.Implant date: not applicable, as lens was not implanted.Explant date: not applicable, as lens was not implanted.Initial reporter: telephone number: (b)(6).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 optic broke in half when the intraocular lens (iol) was delivered into the patient's eye.Account indicated that the surgeon found a broken optic at the end of the tip as the iol was not fully inserted.Despite the gentle handling during removal of the iol from the patient's eye, the torn optic surface damaged the anterior capsule.The capsule remained stable.A back up johnson and johnson iol (model diu150, 21.0 diopter power) was implanted as the replacement lens.There was no delay in treatment or other interventions required.The patient has blurry vision and is being monitored.Visual acuities provided as 0.6 (pre-operative) and 0.7 (post-operative).No further information was provided.

Manufacturer Narrative

Additional information: section d9: device available for evaluation: yes.Date returned to manufacturer: jan 12, 2023.Section h3: device returned to manufacturer: yes.The following was omitted from the initial report and is being corrected in this submission: component codes: 4742 - inserter.Medical device problem code: 2983 - mechanical jam.1384 - mechanical problem.1135 - crack.Device evaluation: visual inspection under magnification revealed that the complaint handpiece was received with the lens stuck inside of the cartridge tip and overridden by the plunger rod.The cartridge tip could be observed to be bulging around the lens and was also observed to be cracked from the tip of the cartridge to the neck of the cartridge.The handpiece was disassembled and the assembly was inspected, no issues that could cause or contribute to the observed issues could be identified.The lens was removed and cleaned, revealing that it was damaged.Inspection of the customer provided photo revealed the lens stuck inside of the cartridge and with the plunger rod overriding the lens.The cartridge tip damage could also be observed in the photo.The complaint issue "delivery issue" was not confirmed.The complaint issue "lens damaged" was observed during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: based on complaint investigation results, there is no indication of a product malfunction or product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data: section h6: component code 4742 - inserter was provided in follow-up #1 report.This code has now been updated to 4755 ¿ part/component/sub-assembly term not applicable.Section h6: in the initial mdr health effect ¿ clinical code 1845 ¿ eye injury was provided.However, in further review the appropriate code for the reported event is 2639 ¿ capsule bag tear (anterior capsule rupture).Section h6: in follow-up #1 medical device problem codes 2983, 1384, and 1135 were provided.However, these codes were inadvertently provided and are not reflective of the initially reported event.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: 16164976
• MDR Text Key: 308639045
• Report Number: 3012236936-2023-00033
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 05050474726437
• UDI-Public: (01)05050474726437(17)250311
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• 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: DIU150I205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2022
• 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 Age: 82 YR
• Patient Sex: Female