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

Model Number DIU300

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/18/2022

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.(b)(4).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.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a diu300 22.0 diopter intraocular lens (iol) was removed from the patient's right (od) eye after being fully inserted due to posterior capsule tear.A vitrectomy, incision enlargement, and suture were required.The replacement lens is a non-johnson and johnson lens.No further information was provided.

Manufacturer Narrative

Section d9.Device available for evaluation? yes.Returned to manufacturer on: may 6 2022.Section h3.Device evaluated manufacturer? yes.Device evaluation: visual inspection under magnification revealed that the handpiece was received with the complaint lens stuck in the cartridge.Inspection of the external assembly revealed that there were no issues with the handpiece.The lens was removed from the cartridge and was cleaned; revealing that the lens was creased where it had been folded inside of the cartridge.No further issues were observed with lens.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 14389837
• MDR Text Key: 292602143
• Report Number: 3012236936-2022-01247
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 05050474747760
• UDI-Public: (01)05050474747760(17)240811
• 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: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DIU300
• Device Catalogue Number: DIU300U220
• 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: 06/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White