MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. - US ELLIPS FX PHACO HANDPIECE; UNIT, PHACOFRAGMENTATION

Model Number	690880
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Toxic Anterior Segment Syndrome (TASS) (4469); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient showed signs of a post-operative infection toxic anterior segment syndrome (tass) the day after surgery on right eye.A small debris was detected during surgery when the phaco tip was in the eye under the blue sleeve.The doctor observed the debris and decided to change the handpiece and phaco tip to continue with the procedure.As a result there is temporary blurry vision.Best corrected visual acuity pre-operative: 6/18 best corrected visual acuity post-operative: 24 hours 6/15, 48 hours 6/30.
Additional Manufacturer Narrative
Section a2 a3, a4 and a5: unknown/ not provided section d6a: if implanted, give date: not applicable, as the handpiece is not an implantable device.Section d6b: if explanted, give date: not applicable, as the handpiece is not an implantable device.Section e1 telephone number: (b)(6).Section h3: the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history record and complaint trending will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: through follow-up, it was learned that the toxic anterior segment syndrome (tass) had been caused by the bausch + lomb (bnl) intraocular lens (iol).Event was re-evaluated and it was concluded there was no adverse event caused or contributed by a jnj device.Therefore, this is not a reportable event and no further information will be submitted.Correction: section h: health effect - clinical code 4469, 2137, 2138 no longer apply and is being updated by 4582.Device code - 1120 no longer applies as this is no longer a reportable event caused by a jnj device.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Correction: the supplemental #1 incorrectly stated the event was no longer reportable.The event remains reportable however; it is no longer a serious injury it is a malfunction event and the code 1120 for device code contamination does apply.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: device evaluation: visual examination revealed brown debris secured to a sample pouch with adhesive.It was noted that the foreign object debris exhibited a matted appearance with somewhat fibrous texture.The adhesive was cut to expose the debris which was subsequently removed for fourier transform infrared (ftir) analysis.Ftir analysis indicates the debris is a mixture containing a cellulose species similar to particleboard (i.E., woodmulch + resin), calcium carbonate, and salts (nacl).The possible detection of an acrylic species may be attributed to the adhesive used to secure the sample.The returned material cannot be traced to the handpieces used, therefore product malfunction and deficiency cannot be confirmed.Manufacturing record review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Conclusion: the returned material cannot be traced to the handpieces used, therefore product malfunction and deficiency cannot be confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: ELLIPS FX PHACO HANDPIECE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. - US; 7500 centurion parkway; jacksonville FL 32256
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 21860744
• Report Number: 3012236936-2025-000109
• Device Sequence Number: 7898512
• Product Code: HQC
• UDI-Device Identifier: 05050474537132
• UDI-Public: (01)05050474537132(17)991231(10)E248768
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K981116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/14/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 690880
• Device Catalogue Number: 690880
• Device Lot Number: E248768
• 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: 03/21/2025
• Supplement Date Received by Manufacturer: 05/08/2025; 08/15/2025; 10/31/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/05/2025; 08/22/2025; 11/14/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VERITAS 202210249
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male