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 04/20/2021

Event Type  Injury  

Manufacturer Narrative

Age/date of birth, weight, ethnicity: unknown/not provided.If implanted, give date: not applicable, as lens was removed in the initial surgery.If explanted, give date: not applicable, as lens was removed in the initial surgery.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the intraocular lens (iol) was inserted into patient's right eye, however, the doctor did not like how the lens was sitting in the eye.The lens was removed during the same procedure, however, no replacement lens was placed.There was no patient injury and no medical interventions were required.No further information was available.

Manufacturer Narrative

Section d9: device available for evaluation:? yes; section d9: returned to manufacturer on: june 09, 2021; section h3: device evaluated by manufacturer? yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification revealed, viscoelastic residue on the optic body and haptics.And that the lens was received cut in half.Which is consistent with a lens, that was handled during removal and replacement.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed.And no product deficiency could be identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.The search revealed, no other investigation request (ir) for this production order number has been received.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.

Manufacturer Narrative

Correction: upon further review, it was determined that the patient leaving aphakic was not a harm.The lens was removed from the patient's eye as the surgeon did not like the way it was sitting in eye and was not due to any product malfunction.Based on our reporting criteria, this complaint is no longer considered a reportable event.Therefore, no further information will be provided under medwatch 2648035-2021-07814.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
• MDR Report Key: 11882424
• MDR Text Key: 258463332
• Report Number: 2648035-2021-07814
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474529069
• UDI-Public: (01)05050474529069(17)220221
• Combination Product (y/n): N
• PMA/PMN Number: P990080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2022
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/26/2021
• Supplement Dates Manufacturer Received: 06/30/2021; 07/15/2021
• Supplement Dates FDA Received: 07/14/2021; 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL: EMERALDC30
• Patient Outcome(s): Required Intervention