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

Model Number PCB00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Glaucoma (1875); Hyphema (1911); Uveitis (2122)

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2019 and (b)(6) 2021.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a pcb00 intraocular lens(iol) was explanted from patient's right eye due to patient having hyphema, glaucoma syndrome and uveitis.The replacement lens used is another johnson and johnson surgical vision lens of same model and diopter.There was no patient injury and no medical/ surgical interventions such as incision enlargement, vitrectomy or sutures were done.Patient was doing fine post-op.No further information available.

Manufacturer Narrative

Section d9: device available for evaluation: yes section d9: returned to manufacturer on: 7/22/2021 section h3: device evaluated by manufacturer: yes device evaluation: the product returned in a plastic bag with a plastic container.Visual evaluation was performed, and the following were the findings.Lens came cut in a half which is associated to the explant wrapped in a gauze.The two (2) haptics were complete.Some particles were in the lens surface.The complaint issue reported was that the lens was explanted due to patient having hyphema, glaucoma syndrome and uveitis.The condition in which the sample returned is consistent with a product that was explanted.Production deficiency can¿t be determined.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.There are no discrepancies found during the mrr (manufacturing record review).A search revealed no additional investigation related to this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 12222333
• MDR Text Key: 263438265
• Report Number: 2648035-2021-08173
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558243
• UDI-Public: (01)05050474558243(17)220328
• Combination Product (y/n): N
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 86