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

Model Number	ZA9003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable as there is no indication that the device was not implanted.If explanted, give date: not applicable as there is no indication that the device was not implanted, thus not explanted.Device evaluation: the product testing could not be performed as the product was not returned for evaluation.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed no other complaints were received for this po.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported the za9003 intraocular lens (iol) trailing haptic broke and there was patient contact.
Additional Manufacturer Narrative
Correction: additional information was received with device return.The following fields were updated: section a-2 patient date of birth: (b)(6) 1947 section e-1 initial reporter title (e.G., mr., ms.): dr.Section e-1 initial reporter first/given name: (b)(6) section e-1 initial reporter middle name: (b)(6).Section e-1 initial reporter last name: (b)(6).Section e-1 initial reporter telephone number: (b)(6).Section e-2 initial reporter health professional? yes.Section e-3 initial reporter occupation: (b)(6).It was reported the patient's affected eye was ocular dexter (right eye).Additional information: section d-9: device available for evaluation: yes section d-9: date returned to manufacturer: 09-mar-2023 section h-3: device evaluated by manufacturer: yes device evaluation: the complaint lens was received inside of the original lens case.Visual inspection under magnification revealed that the complaint lens was received cut in half and with two detached haptics.The lens was cleaned and, no further issues were observed.Based on the return condition of the lens, no further product evaluation could be performed.Complaint issue ¿dc-haptic damaged¿ was not confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: based on the investigation results, there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.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: 16373130
• Report Number: 3012236936-2023-00215
• Device Sequence Number: 6814348
• Product Code: HQL
• UDI-Device Identifier: 05050474529021
• UDI-Public: (01)05050474529021(17)271024
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2023

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 Model Number: ZA9003
• Device Catalogue Number: ZA90030205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/19/2023
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• 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
• Patient Sex: Unknown