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

Model Number	Z9002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Operator of device: location contact from the or (outgoing/receiving) materials department.If implanted, give date: unknown/not provided.If explanted, give date: unknown/not provided.The device was not returned for evaluation as it 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.Attempts have been made to obtain the missing information; 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
Received report indicating the johnson and johnson(jnj) intraocular lens (iol) was damaged.No further information was provided.
Additional Manufacturer Narrative
Corrected data.This is to correct the initial submission section e1, reporter name and address: title, first name and last name are incorrect.The fields below are updated.Section e1, reporter title: (b)(6).Section e1, first name: unknown/not provided.Section e1, last name.(b)(6).Section e2, health professional states no, but should have been yes.And section e3, occupation states non-healthcare professional but should have stated (b)(6).Below are the corrected fields.Section e2, health professional?: yes.Section e3: occupation: (b)(6).Additional data.Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: may 5, 2023.Section h3: evaluated by manufacturer: yes.Device evaluation: the suspect intraocular lens (iol) was cleaned and visual inspection under magnification found a damaged haptic, and scratches on the lens surface.No further issues were identified, and no further evaluation was performed.The observed issues during product evaluation could not be confirmed to be related to the manufacturing or design process.Conclusion: based on the complaint investigation results, the product was released within specifications and a relationship between the device and the reported incident could not be determined.There is no indication of a product deficiency or product malfunction could be identified.Please note that the information reported in sections d2 (common device name), h.6 (health effect -clinical code and medical device problem code) and section g.1 (manufacturer contact e-mail) is information that remains unchanged from the initial emdr report.Resubmitting follow up 1 as follow up 2 due to an error in the first submission.Follow up 1 was initially submitted on june 9, 2023.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Additional Manufacturer Narrative
Corrected data.This is to correct the initial submission section e1, reporter name and address: title, first name and last name are incorrect.The fields below are updated.Section e1, reporter title: dr.Section e1, first name: unknown/not provided.Section e1, last name.(b)(6).Section e2, health professional states no, but should have been yes.And section e3, occupation states non-healthcare professional but should have stated physician.Below are the corrected fields.Section e2, health professional?: yes.Section e3: occupation: physician.Additional data.Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: may 5, 2023.Section h3: evaluated by manufacturer: yes.Device evaluation: the suspect intraocular lens (iol) was cleaned and visual inspection under magnification found a damaged haptic, and scratches on the lens surface.No further issues were identified, and no further evaluation was performed.The observed issues during product evaluation could not be confirmed to be related to the manufacturing or design process.Conclusion: based on the complaint investigation results, the product was released within specifications and a relationship between the device and the reported incident could not be determined.There is no indication of a product deficiency or product malfunction could be identified.Please note that the information reported in sections d2 (common device name), h.6 (health effect -clinical code and medical device problem code) and section g.1 (manufacturer contact e-mail) is information that remains unchanged from the initial emdr report.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

• Brand Name: TECNIS CL 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: 16621574
• Report Number: 3012236936-2023-00733
• Device Sequence Number: 7305968
• Product Code: HQL
• UDI-Device Identifier: 05050474530652
• UDI-Public: (01)05050474530652(17)220130
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• 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,Followup
• Report Date (Section B): 06/14/2023

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: Other
• Device Expiration Date: 01/30/2022
• Device Model Number: Z9002
• Device Catalogue Number: Z900200180
• 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: 03/14/2023
• Supplement Date Received by Manufacturer: 05/15/2023; 05/15/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 06/09/2023; 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2017
• 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