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

Model Number	ZCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Zonular Dehiscence (2698)
Date of Event	07/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The surgery center reported in / out of an intraocular lens (iol).After cataract extraction, a lens that was completely implanted in a patient's left eye (os) was removed and replaced during the same procedure as the surgeon was concerned with the integrity of the posterior capsule (pc) bag / zonules; therefore, used a 3-piece lens, model za9003 of 16.5 diopter as a replacement.It was confirmed that there was no product quality issue.There was other medical / surgical intervention required: ac tap was performed x2 (1 hour apart) to lower intraocular pressure (iop) as it was slightly elevated; 5% betadine was placed prior to both ac taps, and a drop of moxifloxacin was placed after both pilocarpine 1% 1drop twice a day (bid) os x2 days (to help clear any remaining viscoat).The patient outcome was not provided.No further information was provided.
Additional Manufacturer Narrative
Section d6a: if implanted, give date: not applicable, as lens was removed / replaced during the same surgery.Section d6b: if explanted, give date: not applicable, as lens was removed / replaced during the same surgery.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, 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.An attempt was made to obtain the missing information; however, the information was not available.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: in review, it was noticed that the health effect - clinical code of "1937" was inadvertently not entered in the initial mdr report; therefore, the information has been captured in this supplemental mdr report.The following field was updated accordingly: section h6: health effect - clinical code: 1937 - intraocular pressure increased.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: 17647141
• Report Number: 3012236936-2023-02215
• Device Sequence Number: 6062839
• Product Code: HQL
• UDI-Device Identifier: 05050474531666
• UDI-Public: (01)05050474531666(17)261108
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2023

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 Model Number: ZCB00
• Device Catalogue Number: ZCB0000175
• 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: Not provided
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown