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

Model Number	ZLB00
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the non-preloaded intraocular lens (iol) was inserted in the eye and the capsule was spontaneously broken.The lens was cut out and removed.The wound was enlarged and a non-johnson and johnson iol was injected.The surgeon told the patient that the left eye did not have the support to put in the lens, so a non-johnson and johnson iol had to be placed in the sulcus the next day, at post-op day 1 visit, the surgeon told the patient that up until inserting the lens in the left eye, the surgery "was textbook".However, when the lens was inserted the capsule tore due to the lens not unfolding; the lens tore the capsule.The patient reported being told that the lens was cut out of eye because the lens was floating towards the retina.The patient noted that the right eye cataract surgery was done years ago and this left eye surgery felt very different than the previous surgery on the other eye, in that this surgery was painful.The patient had pre-operative visual acuity of 20/300.The patient reported that she does not have any pre-existing ocular conditions.The patient was told that the removed johnson and johnson lens was destroyed.With the implanted non-johnson and johnson lens, the patient reports having issues of flashes of light, floaters, cobwebs, and also has acute conjunctivitis in both eyes.The patient also reported an issue with ¿something in the pupil¿ that was described as ¿a little triangle in the pupil¿.The patient can see at a distance, but now requires glasses to read and do close up work.The patient is on the standard medications for post-op but also on tobramycin with prednisone for the conjunctivitis and mentioned also being on prolensa (nsaid).The patient noted having a lot of allergies to medications.There are no planned interventions at this time.No further information was provided.
Additional Manufacturer Narrative
Section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section h3-other (81): the device was not returned for evaluation as it was discarded; 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.Section h6: health effect - clinical code: code 4581 is to capture incision enlarged.Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 16811061
• Report Number: 3012236936-2023-00999
• Device Sequence Number: 2933640
• Product Code: MFK
• UDI-Device Identifier: 05050474560703
• UDI-Public: (01)05050474560703(17)250717
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/25/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/17/2025
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0215
• 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: 03/29/2023
• Initial Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2021
• 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: Required Intervention
• Patient Sex: Female