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

Model Number	DIU150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Conjunctivitis (1784); Inflammation (1932); Intraocular Pressure Increased (1937); Red Eye(s) (2038); Blurred Vision (2137); Eye Infections (4466); Eye Pain (4467)
Date of Event	09/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after the preloaded intraocular lens (iol) was implanted in the right eye (od), the patient left the procedure feeling fine and then came back with an infection.About four to fifteen days after the procedure, the patient began to feel discomfort, increased irritation, inflammation and infection.A culture was collected and was negative for growth.Through follow-up, it was learned that the patient¿s od distance va with correction (cc) was 20/25 pre implant (brightness acuity test (bat) to 20/50-2) on (b)(6) 2023.On (b)(6) 2023, prior to the implantation of the lens, the patient¿s va was 20/40 -2 (unknown if corrected or uncorrected).The patient's va after the implantation of the lens was 20/20-2 (on (b)(6) 2023).It is unknown if the patient's daily activities were affected.Medical intervention of tap/injection was performed on (b)(6) 2023.The intraocular pressure (iop) was 12 in right eye (od) prior to tap (on (b)(6) 2023).After tap, iop was 49.The patient was given diamox 500mg and cosopt/alphagan and the patient was started on levaquin oral 500mg/day x 10 days.Prior to the patient leaving, iop was 23.It is unknown if the elevated iop lasted longer than 15 days.As of the (b)(6) 2023, ¿vision is still foggy, and does not feel much better.¿ the patient also complained of irritation, hazy vision, yellow discharge and the patient states the vision has decreased.The patient va was 20/50.On (b)(6) 2023, the od distance without correction (sc) was 20/25-2 post implant (as the patient has not been refracted yet).The patient¿s medical records state ¿possible endophthalmitis.¿ a culture was done, and the results were negative.The patient¿s prescribed other medications were restasis, thorazine, lutein, prednisolone acetate (pa).The doctor is monitoring the patient and the doctor has begun to taper the ocular medications as the vision has improved.Another follow-up will be done on (b)(6) 2023.The lens remains implanted.The facility will be looking into what is being re-used during surgery and convert to single use only, as the customer noted that the cannulas used are re-usable.No further information was provided.
Additional Manufacturer Narrative
Section d6b: if explanted, give date: not applicable, as the lens remains implanted.Section h3-other (81): the device was not returned for evaluation as it remains implanted; 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 17927666
• Report Number: 3012236936-2023-02604
• Device Sequence Number: 6368338
• Product Code: MJP
• UDI-Device Identifier: 05050474746411
• UDI-Public: (01)05050474746411(17)240928
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2024
• Device Model Number: DIU150
• Device Catalogue Number: DIU150U135
• Was Device Available for Evaluation?: No
• 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: Not provided
• Initial Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Hispanic
• Patient Race: White