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

Model Number	ZLB00
Health Effect - Clinical Codes	Macular Edema (1822); Blurred Vision (2137); Visual Disturbances (2140); Eye Pain (4467)
Date of Event	11/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information: unknown as information was not provided.Explanted date: not applicable, as the iol remains implanted in the patient's os.It was indicated that the iol is not being returned for evaluation as it remains implanted in the patient¿s os therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and historical data analysis for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.H3 other text : iol remains implanted.
Event or Problem Description
The intraocular lens (iol) was implanted in the patient's ocular sinister (left eye).Patient reported, shortly after the surgery, complaints of os being uncomfortable-irritating, sore, feels like she wore contact lenses too long.She uses artificial tears when needed.Patient reported uncomfortable feeling as same or better now.Patient can see the outline of the iol, which was noticed right after surgery.Near vision is poor and has difficulty working on the computer and reading.Results are not as expected.Distance vision is good, approximately 20/25.Os had cloudiness which was corrected by laser, cloudiness is now better.Through follow-up, additional information was received stating possible swelling of the retina.No further information is available.This report captures the iol in the patient's ocular sinister (left eye).A separate report will be filed for the patient's ocular dexter (right eye).
Additional Manufacturer Narrative
Device evaluation: product testing could not be performed, because the product remains implanted in the patient's eye.A product quality deficiency could not be confirmed.The reported issue was not verified.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 revealed, that no other complaints for this production order number have been received.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: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 11335981
• Report Number: 2648035-2021-07248
• Device Sequence Number: 934650
• Product Code: MFK
• UDI-Device Identifier: 05050474560529
• UDI-Public: (01)05050474560529(17)221130
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2021

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: 11/30/2022
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0125
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention