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

Model Number	DFW150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	09/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was implanted in the patient's ocular sinister (left eye) and explanted during a separate secondary surgical procedure due to complaints of not correcting patient's vision well.Visual acuities provided as 20/60 sc (without correction) and 20/30 cc (with correction).Patient indicated that they cannot read well as vision is very blurry.The iol was replaced with a different model lens of the same diopter size.There was no patient injury reported.Through follow-up additional information was received confirming that no additional surgical intervention was required.Patient outcome 1 day post-procedure was reported as excellent with visual acuity readings 20/30 sc (without correction).No further information is available.
Additional Manufacturer Narrative
Device evaluation: product evaluation could not be performed since, at the time of this investigation, the product had not been received.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search of complaints revealed that one (01) additional complaint folder was found as part of this production order (po) number.Complaint was voided and based on the complaint history review (chr) results, no escalation was required.Conclusion: as a result of the investigation, there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: MULTIFOCAL INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 1700 e. st. andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12708548
• Report Number: 2020664-2021-07877
• Device Sequence Number: 13842491
• Product Code: MJP
• UDI-Device Identifier: 05050474751149
• UDI-Public: (01)05050474751149(17)240405
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 12/18/2021

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: 04/05/2024
• Device Model Number: DFW150
• Device Catalogue Number: DFW150U140
• 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: 10/06/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 12/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DFW150 CARTRIDGE, LOT UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White