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 Code	Visual Impairment (2138)
Date of Event	10/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age or date of birth, weight, ethnicity: unknown/ not provided.Asku.Date of event: unknown, not provided.Best estimate of date of event is between oct 3, 2022 and dec.5, 2022.If explanted, give date: unknown/not provided.The device is not returned; 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 information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that patient needed different diopter intraocular lens (iol) hence lens was explanted.There was no incision enlargement, vitrectomy or sutures done.Patient doing well post-op and no injury reported.No other information was provided.
Additional Manufacturer Narrative
Additional information: further information received that eye affected was left eye.There was refractive surprise and the patient was left more myopic than aimed for, patient was unhappy with blurred vision for distance, patient is a truck driver and needs distance.Patient opted for a non-johnson and johnson iol to decrease astigmatism and maintain intermediate vision than with toric iol.Date of event noted to be (b)(6) 2022.Explant date (b)(6) 2022.Patient age: 49 yrs.Old, weight:160 lbs.Doctor's name: (b)(6).Fields below updated: section a2 and a4: 49 yrs.Old, 160 lbs.Section b2: date of event: (b)(6) 2022.Section d6b: if explanted: give date: (b)(6) 2022.Section e1: complaint reporter first and last name: dr.(b)(6).Section e2: healthcare professional: yes.Section e3: occupation: physician.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Section d9.Device available for evaluation? yes.Returned to manufacturer on: feb.13, 2023.Section h3.Device evaluated manufacturer? yes.Device evaluation: visual inspection under magnification revealed that the suspect lens was received cut in half and coated in viscoelastic residue.The lens was cleaned and inspected under magnification and scratches were observed on the surface of the lens.Lens damage was also observed on the lens around the haptic.No further issues were identified.The complaint issue "explant" and ¿unexpected postop refraction¿ 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.Conclusion: as a result of the investigation, there is no indication of a product deficiency or product malfunction.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: 15979747
• Report Number: 3012236936-2022-03087
• Device Sequence Number: 17588533
• Product Code: MJP
• UDI-Device Identifier: 05050474746572
• UDI-Public: (01)05050474746572(17)241105
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2023

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: 11/05/2024
• Device Model Number: DIU150
• Device Catalogue Number: DIU150U215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/05/2022
• Supplement Date Received by Manufacturer: 12/15/2022; 02/22/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 12/19/2022; 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2021
• 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 Age: 49 YR
• Patient Sex: Male
• Patient Weight: 73 KG