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

Model Number	ZA9003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a4, a5 patient information: asked.Customer declined due to patient privacy.Section d6a, if implanted, give date: not applicable as the iol was removed and replaced during the same procedure.Section d6b, if explanted, give date: not applicable as the iol was removed and replaced during the same procedure.Therefore, not explanted.Section h3-other (81): the device has not been 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 the missing information.However, to date, it has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the haptic bent on the johnson and johnson(jnj) intraocular lens (iol).As they were placing the lens in the left eye the haptic bent.The iol was cut in half and removed.The lens was replaced with the same model but 15.5 diopter.There were no other complications such as capsule tear, vitrectomy, or sutures.No further information was provided.
Additional Manufacturer Narrative
Additional information.Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: apr 11, 2024.Section h3: evaluated by manufacturer: yes.Device evaluation: the lens was visually inspected under magnification revealing that the lens was cut in half and coated in viscoelastic residue.The lens was cleaned and inspected revealing one haptic was slightly bent.Damage on the edge of the lens was also observed.Based on the complaint investigation results, the product was released within specifications.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.
Additional Manufacturer Narrative
Correction: in review it was noticed that an incorrect date (apr 4, 2024) was entered in section b4, of the follow-up report# 3012236936-2024-00667.The information has been corrected in this supplemental mdr report and the following field was updated.Section b4, date of this report apr 29, 2024.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: 18955813
• Report Number: 3012236936-2024-00667
• Device Sequence Number: 15793925
• Product Code: HQL
• UDI-Device Identifier: 05050474528918
• UDI-Public: (01)05050474528918(17)270825
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/25/2024; 05/01/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 04/29/2024; 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2022
• 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
• Patient Sex: Unknown