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

Model Number	DFW150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	05/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was experiencing blurry vision and glare around point sources of light in their left eye (os) resulting in the need to explant the intraocular lens (iol).The patient's pre-operation best corrected visual acuity (bcva) is 20/50.The patient's post-operation uncorrected visual acuity (ucva) is 20/50 and bcva 20/40.The targeted post-operation refraction was 20/20 both eye.No incision enlargement, vitrectomy, or sutures were required.The replacement iol was a different johnson and johnson lens (model diu150,18.5 diopter).There was no reported patient injury.No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: the device was not returned at the manufacturing site, as it is still implanted; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.A search of complaints related to this production order (po) was performed.The search in complaint system revealed 1 other complaint has been received for this po number and it was voided as it was a duplicate serial number.No escalation was required.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.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: 11/21/2022 section h3: device evaluated by manufacturer¿ yes device evaluation: the product was returned to the manufacturing site for evaluation.The complaint lens was received inside of a specimen cup.Visual inspection under magnification revealed that the complaint lens was received cut in half.The lens was cleaned and, no issues that could cause or contribute to the complaint issues could be identified.Based on the return condition of the lens, no further product evaluation could be performed.As a result of the investigation there is no indication of a product deficiency or product malfunction.Correction: upon further review of the file, it was noted that the following information (in section h10-narrative field, device evaluation) should be corrected as it is incorrect in initial report, mdr # 3012236936-2022-02745: it was noted that the device was not returned at the manufacturing site, as it was still implanted.However, this is incorrect as the device was already explanted.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 was inadvertently not included in the initial report (mdr # 3012236936-2022-02745): after the explant, the patient is reported to have good post-operative appearance with visual acuity (va) of 20/30.Additionally, there are no planned interventions for the patient.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 15741063
• Report Number: 3012236936-2022-02745
• Device Sequence Number: 6317308
• Product Code: MFK
• UDI-Device Identifier: 05050474751248
• UDI-Public: (01)05050474751248(17)241123
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/28/2022

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: 11/23/2024
• Device Model Number: DFW150
• Device Catalogue Number: DFW150U190
• 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: 10/19/2022
• Supplement Date Received by Manufacturer: 11/08/2022; 12/16/2022
• Initial Report FDA Received Date: 11/05/2022
• Supplement Report FDA Received Date: 12/02/2022; 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2021
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White