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

Model Number	DIU300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	06/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's vision did not improve and was still blurry following surgery on their left eye (os) resulting in the need to explant the intraocular lens (iol).The intended/targeted post-operative refraction was plano and intended refractive focal point was distance vision.The patient's pre-operative best corrected visual acuity (bcva) was 20/40.The patient's post-operative uncorrected visual acuity (ucva) was 20/40 and bcva 20/20.It was stated that the patient had an old corneal scar that interfered with the optical biometry measurements.Due to this the patient was sent for a pentacam to confirm the keratometry readings.There was no reported patient injury.The patient is stated to be doing well following the explant during which a different model lens of higher diopter power was implanted (tecnis toric ll lens model zcu150, +9.0 diopter) current ucva provided as 20/20.No additional information was provided.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was not returned for evaluation; 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 and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes section d9: returned to manufacturer on: 9/19/2022 section h3: device evaluated by manufacturer¿ yes device evaluation: the complaint lens was received in a specimen cup.The lens was cleaned and no defects including those that could contribute to visual issues were observed under magnification.The complaint issue ¿hs-unexpected postop refraction¿ was not confirmed.Therefore, there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: upon further review of the file, it was noted that the following information should be corrected as it was missed in the initial report (mdr # 3012236936-2022-02124): the patient additionally had incision enlargement during their explant procedure.All pertinent information available to johnson and 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: 15280201
• Report Number: 3012236936-2022-02124
• Device Sequence Number: 2393373
• Product Code: MJP
• UDI-Device Identifier: 05050474747470
• UDI-Public: (01)05050474747470(17)240526
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/05/2022

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: 05/26/2024
• Device Model Number: DIU300
• Device Catalogue Number: DIU300U075
• 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: 07/29/2022
• Supplement Date Received by Manufacturer: 10/05/2022; 10/05/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 10/05/2022; 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2021
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White