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

Model Number	ZCB00
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information : 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; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint history for production order 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 or Problem Description
It was reported that non-preloaded monocular intraocular lens (iol) with model zcb00 displaced inferionasally.Surgeon had to cut out and use backup lens with model za9003 in same surgical procedure.Sutures were required, after a new lens, the patient recovered without issue.Additional information revealed that the surgery proceeded normally with lens removal.The capsular bag was re-inflated with viscoelastic and the capsular bag was intact.The zcb00 lens was placed in the eye using a shooter and allowed to unfold in the capsular bag.The inserter was not advanced into the anterior chamber.A kuglen hook was used to push the trailing haptic from the anterior chamber into the capsular bag, and a tear in the posterior capsule was seen with the leading haptic going through the tear.Iol was brought back into the anterior chamber and removed from the eye by cutting each lens into three pieces and replacing them with a three-piece sulcus lens.Patient has been referred to a retina specialist for evaluation because the sulcus iol dislocated.Appointment is scheduled for 9/14/2023.No further information is available.

• 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: 17864964
• Report Number: 3012236936-2023-02404
• Device Sequence Number: 5929749
• Product Code: HQL
• UDI-Device Identifier: 05050474531918
• UDI-Public: (01)05050474531918(17)240507
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/03/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/07/2024
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000300
• 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: 09/08/2023
• Initial Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2020
• 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: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Hispanic
• Patient Race: White