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

Model Number	ZA9003
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	07/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the non preloaded intraocular lens (iol) was stuck in the cartridge.Bss was used at the room temperature and duovisc was also pulled approximately 1 hour before application.It was loaded and directly handed off to the surgeon.The lens was moved closer to the tip and was partially inserted.The issue was observed during insertion.There was no patient injury.Vitrectomy was required and was thought it was due to removal of natural lens.It was not known if it was the jnj device that removed the natural lens caused capsular tear.Patient had full recovered.No other information is available.
Additional Manufacturer Narrative
Section a3b, a4 and a5: unknown/ asked but not available.Section b3: date of event: unknown, not provided.Section d6a: if implanted, give date: unknown, information not provided.Section d6b: if explanted, give date: unknown, information not provided.Section e1: surgeon's email address and phone number: unknown/ asked but not available.Section h3: 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.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: upon review it was noted that section a3: gender and section e1: email address were missed in the initial report submitted.Where both sections should have been populated.Also in section b2: outcome attributed to adverse event, "other serious (important medical events)" should not have been populated.Lastly, in h11 text it was indicated in the initial report submitted that "section b3: date of event: unknown, not provided".But this was actually indicated in the initial report submitted in section b3: date of event: july 22, 2024.This follow-up report is being submitted to correct these.Fields below updated accordingly: section a3: gender: cisgender man/boy.Section e1: email address: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: 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: 20021040
• Report Number: 3012236936-2024-000226
• Device Sequence Number: 12909103
• Product Code: HQL
• UDI-Device Identifier: 05050474528994
• UDI-Public: (01)05050474528994(17)250609
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/09/2025
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 89 YR
• Patient Sex: Male