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

Model Number	ZXR00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date implanted: not applicable, as the iol was removed/replaced during the same procedure.Date explanted: not applicable, as the iol was removed/replaced during the same procedure.The device was not returned for analysis as the product 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported the intraocular lens (iol) was implanted in the patient's ocular sinister (left eye) and the trailing haptic was messed up, bent and subsequently folded then broke.The doctor could not fix the haptic and the lens was cut out.Another johnson & johnson surgical vision (jjsv) lens with the same model and diopter size was implanted without difficulty.Reportedly, there was bleeding caused by maneuvers performed to extract the lens.It was confirmed that there was no patient injury and balanced salt solution (bss) tamponade was used to control bleeding.There was no capsule damage reported.Patient had no pre-existing eye or health conditions and their outcome post-procedure was reported to be good.The iol is not available for return as it was discarded.No further information is available.

• Brand Name: TECNIS IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 12485748
• Report Number: 2020664-2021-07362
• Device Sequence Number: 3350442
• Product Code: POE
• UDI-Device Identifier: 05050474579057
• UDI-Public: (01)05050474579057(17)251123
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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 faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2021

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: 11/23/2025
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1MTEC30 CARTRIDGE LOT UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 73