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

Model Number	ZA9003
Medical Device Problem Codes	Material Fragmentation (1261); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: patient weight and ethnicity: unknown as information was not provided.The device is not available 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 and historical data analysis for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was initially reported the intraocular lens (iol) was broken.Through follow-up, additional information was provided confirming partial contact with patient as the doctor attempted to insert the iol in the patient's ocular dexter (right eye), and the hook broke off, thus breaking the lens.There was no patient injury and no unplanned suture(s).It is unknown if the incision was enlarged, however a planned vitrectomy was performed.The procedure was completed successfully using back-up lens with the same model and diopter size.The damaged lens was discarded.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
• MDR Report Key: 11861311
• Report Number: 2648035-2021-07720
• Device Sequence Number: 3789379
• Product Code: HQL
• UDI-Device Identifier: 05050474528857
• UDI-Public: (01)05050474528857(17)230404
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2021

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 Expiration Date: 04/04/2023
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030120
• 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: 04/23/2021
• Initial Report FDA Received Date: 05/21/2021
• 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: CARTRIDGE MODEL AND LOT# UNKNOWN
• Patient Age: 75 YR