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

Model Number	ZA9003
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age or date of birth, weight, and ethnicity: unknown, not provided.If implanted; give date: n/a (not applicable).Lens was not inserted and a back up lens was used during the same procedure.If explanted; give date: n/a (not applicable).Lens was not inserted and a back up lens was used during the same procedure.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a tecnis intraocular lens (iol) back haptic was bent/broken when loading in the cartridge.There was patient involvement.The lens was not inserted and the procedure was completed using a back up lens.Reportedly, the patient has recovered.No further information was provided.
Additional Manufacturer Narrative
In review, it was noted that the following information inadvertently was not mentioned in the section ¿b5¿ of the initial mdr report; therefore, the information is captured in this supplemental mdr report as indicated below: there was patient contact, and the affected eye was the left eye (os).There was no incision enlargement required.The outcome did not significantly interfered with patient¿s activities of daily life.Device available for evaluation? yes.Date returned to manufacturer: aug 27, 2021.Returned to manufacturer: yes.Device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification after cleaning the lens, revealed a bent haptic.The complaint issue was confirmed; however, based on the fact that the lens was handle during loading this issue can be attributed to handling and cannot be confirmed to be related to manufacturing, and therefore no product deficiency could be identified.Manufacturing records review: the manufacturing records review was performed, and no nonconformity report was found as part of this manufacturing records review.The product was manufactured and released according to specifications.A search in complaint system revealed one additional complaint was received for this production order number.Although the complaint issues reported are related, no further investigation was required for that one case and therefore, no escalations are required.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.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 ; road 402 north, anasco ind. pk; anasco, PR 00610 ; 7142478552
• MDR Report Key: 12317100
• Report Number: 2648035-2021-08298
• Device Sequence Number: 14203777
• Product Code: HQL
• UDI-Device Identifier: 05050474528994
• UDI-Public: (01)05050474528994(17)230621
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2021

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: 06/21/2023
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• 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: 07/15/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EMERALDC, LOT CH08447; EMERALDC, LOT CH08447
• Patient Sex: Unknown