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

Model Number ZA9003

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2023

Event Type  Injury  

Manufacturer Narrative

Section d6a: if implanted; give date: n/a.The intraocular lens was inserted and removed during the same procedure.Section d6b: if explanted; give date: n/a.The intraocular lens was inserted and removed during the same procedure.Section h3: other 81: the device was not returned for evaluation.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 missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the non preloaded monofocal intraocular lens (iol) lens was not sitting right.Doctor was able to remove the inserted iol.A different lens of the same model was used without any issues during same procedure.The patient's post-procedure status is good.No further information is available.

Manufacturer Narrative

Additional information: section d-9: device available for evaluation: yes; section d-9: device date returned to manufacturer: 28 -nov-2023; section h-3: device evaluated by manufacturer: yes.Device evaluation: visual inspection revealed that the lens was received cut in half.The lens was cleaned and damage on one half of the lens was observed, consistent with a lens that was cut and explanted.No issues that could cause or contribute to the complaint issue was observed.The complaint issue "positioning issue" was not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.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 was performed.The search revealed that no other complaints were received for this purchase order.Conclusion: the complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Type of Device: 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: 18233943
• MDR Text Key: 329315713
• Report Number: 3012236936-2023-02892
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474529021
• UDI-Public: (01)05050474529021(17)280414
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female