MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS SYNERGY; INTRAOCULAR LENS

Model Number DFR00V

Device Problems Material Discolored (1170); Material Opacification (1426)

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

Event Date 07/16/2021

Event Type  malfunction  

Manufacturer Narrative

Phone number: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a faint turbidity was noticed on the entire peripheral part of an intraocular lens (iol), that the surface of the lens optic appeared to be white, covered with a film when the lens was implanted in the left eye of a patient.The lens was removed during the same surgery.No further information was provided.

Manufacturer Narrative

Additional information: additional information provided indicated that the sodium hyaluronate manufactured by a competitor company was injected into the injector and the ovd (ophthalmic viscosurgical device) injected into the eye and sac was healon.Additionally, the doctor indicated that it appears that more foreign material is attached to one side of the lens (the part that touches the side of the cartridge during implanting).It is the doctor assumption that the substance coated on the cartridge attached to this product may have been scraped off and adhered to the surface of the lens when it passed through the cartridge before surgery.Additional information received also indicated that a replacement lens successfully implanted during the same/initial surgery.There was no patient injury reported.The following fields were updated accordingly: section h6: health effect - impact code: 4631.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data: in review, it was noted that the patient's race and ethnicity was inadvertently not entered in the initial mdr report; therefore, the information has been captured in this supplemental mdr report and the following fields were updated accordingly: section a5: ethnicity: not hispanic/latino.Section a5: race: asian.Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer: yes.Section d9: date returned to manufacturer: aug 23, 2021.Section h3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received submerged in balanced salt solution (bss) along with an unknown specimen inside a bottle.The original folding carton, used preloaded handpiece with tray, patient stickers, implant notification card, patient identification (id) card, direction for used (dfu), and an opened sealed pouch were received as well.A dvd containing a customer provided video of the surgery and customer notes were also received.The lens was rinsed with deionized water, but not cleaned or swabbed.Visual inspection under magnification revealed viscoelastic residue on the optic body, which is consistent with a lens that was handled during removal.Dimensional inspection was performed, and the lens measured within specifications.There was no assembly issue identified, the device plunger was in advance position and locked.The handpiece was disassembled, and viscoelastic residue was observed inside the smartload assembly (no foreign material observed inside handpiece).The lens was forwarded to the johnson & johnson (j&j) santa ana lab for further analysis via ultra violet-visible spectroscopy (uv-vis) and fourier transform infrared (ftir) testing.Infrared spectrum is typical for optiblue / sensar acrylic.Uv-vis-nir transmission spectrum is typical for optiblue intraocular lenses (iols).No evidence of haze / discoloration or a decrease in %t was observed.The solution and specimen inside the returned bottle was forwarded to the j&j jacksonville r&d lab for further inspection.Fluorescein, a common ophthalmic stain, was suspected as the source of haze in an iol device as the source of the customer complaint.R&d analytical chemistry was requested to measure the saline solution for the presence of fluorescein using liquid chromatography/mass spectrometry (lc/ms).Analysis by lc/ms did not detect fluorescein in the test sample at quantifiable levels.The lens was forwarded to an independent laboratories for further analysis via scanning electron microscopy (sem).The complaint lens surface contained agglomerations of salt (e.G., nacl, kcl, etc.) and alumina / aluminosilicate (al2o3, alxsiyoz) particles and exhibited texture along some portions of the anterior half of the haptic and body.Salt agglomerations appear as amorphous and/or large rock-like structures, while the alumina / aluminosilicate particles appear as bright white, small spherical particles.Agglomerations were observed in all locations.The reference lens was considerably cleaner, although some texture was identified on the posterior half of the body.The complaint issue could not be confirmed, and no product deficiency could be identified.Furthermore, product from this complaint complaint production order were obtained from distribution.Visual inspection, dimensional inspection, and yellow-filter testing revealed no manufacturing defects with the devices.A conclusion from the j&j subject matter expert (sme) was provided and confirms that "there were no abnormalities confirmed during the inspection of the returned lenses"."based on current information and the collective laboratory test results in this investigation, both the explanted and unused returned synergy iols did not exhibit any observable non-conformances that may compromise its safe and effective use".Manufacturing records review: the manufacturing process record was evaluated, and no discrepancies were found during the mrr (manufacturing record review) related to this complaint issue reported.The units were manufactured and released according to specifications.A search in complaint system revealed that no other complaints have been received for this production order number.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 SYNERGY
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; van swietenlaan 5; groningen, groningen 9728 -NX ; NL 9728 NX
• MDR Report Key: 12319749
• MDR Text Key: 266955597
• Report Number: 9614546-2021-07332
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474709706
• UDI-Public: (01)05050474709706(17)230910
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2023
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VI115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2020
• 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 Age: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian