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

Model Number	PCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No patient involvement.If implanted, give date: not applicable, as lens was removed and replaced in initial surgery.If explanted, give date: not applicable, as lens was removed and replaced in initial surgery.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that a pcb00 intraocular lens (iol) was fully inserted, then removed and replaced in the same procedure due to lens falling to back of the eye, unable to place.The lens and cartridge contacted patient's eye.Additional information received indicated that there were no medical intervention, no sutures, no injury and no incision enlargement.No further information is available.
Additional Manufacturer Narrative
Device evaluation: the device was not received.Therefore, the sample evaluation could not be performed, the reported issue could not be verified and product deficiency could not be determined.Manufacturing records review: there are no discrepancies found during the mrr (manufacturing record review) related to this complaint.The units were released according specification in compliance with the product intended use as required.A review complaints related to this production order was performed.No additional complaint has been received.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.
Additional Manufacturer Narrative
Section d9.Device available for evaluation? yes.Returned to manufacturer on: 5/19/2021.Section h3.Device evaluated by manufacturer? yes.Device evaluation: after the visual evaluation performed the following are the observations: there was no lubricant residues observed.The lens stuck in cartridge and cartridge tip deformed/damage.The plunger and push rod were observed in advanced position.The pushrod was observed that overrides the lens in the cartridge.The lens haptic was not folded.The complaint issue was not verified.The condition in which the sample returned is consistent with a product that was handled and prepared for a surgical process.No product quality deficiency was identified.Conclusion: as a result of the investigation there is no indication of a product quality 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: 11548590
• Report Number: 2648035-2021-07425
• Device Sequence Number: 4140742
• Product Code: HQL
• UDI-Device Identifier: 05050474558250
• UDI-Public: (01)05050474558250(17)230805
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/04/2021

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: No Information
• Device Expiration Date: 08/05/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 03/30/2021; 06/10/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 04/27/2021; 07/04/2021
• 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: Other