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

Model Number	ZCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event; exact date is unknown, not provided.Best estimate is between (b)(6) 2021 - (b)(6) 2021.If implanted; give date: unknown/not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the tecnis monofocal intraocular lens (iol) was removed from the patient's right (od) eye in a secondary procedure because of a myopic surprise.A replacement lens is the same model at a lower diopter (8.5).There was no additional intervention.Reportedly, the patient is doing fine post-exchange.No further information provided.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes section d9: return to manufacturer: 3/25/2021.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics and that the lens was received cut in half, which is consistent with a lens that was handled during explant.Furthermore, fibers were observed on the lens which can be attributed to receiving the lens stuck to a piece of paper and therefore cannot be confirmed to be related to manufacturing.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.Historical data analysis: a search of complaints revealed no other complaints have been received for this production order number.Conclusion: as a result of the investigation, there is no indication of a quality product deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 11626088
• Report Number: 2648035-2021-07407
• Device Sequence Number: 3279511
• Product Code: HQL
• UDI-Device Identifier: 05050474531536
• UDI-Public: (01)05050474531536(17)240809
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• 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 faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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: 08/09/2024
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 04/24/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 05/20/2021
• 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