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

Model Number	PCB00
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Eye Injury (1845); Hyphema (1911); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age or date of birth, weight, and ethnicity: information unknown not provided.If implanted, give date: not applicable as the lens was not implanted.If explanted, give date: not applicable as the lens was not implanted.Reporter phone number: (b)(6).Device evaluation: the preloaded unit was not returned for evaluation.Therefore, a failure analysis of the complaint device could not be performed.Manufacturing record evaluation: the device manufacturing records were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
During the injection of the intraocular lens into the patient¿s eye, the lens appeared without a haptic loop.The haptic loop was inside the injector and detached from the lens.The lens had to be cut to be explanted.There was a 15 minute delay as the patient had an iris emorragy (hemorrhage), no other lens can be implanted.An incision enlargement and sutures were required.A vitrectomy was indicated as probably being needed the next day.The device was noted not available for investigation.No additional information provided.
Additional Manufacturer Narrative
Corrected data: section h6: health effect: clinical code was inadvertently populated in initial mdr.It should not have been populated as 4581 at all.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: upon further review it was noted that the lens was removed during the same surgery and patient suffered from hyphema.Section below updated.Section h6- clinical code : hyphema all pertinent information available to johnson and 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: 11899640
• Report Number: 2648035-2021-07858
• Device Sequence Number: 3687810
• Product Code: HQL
• UDI-Device Identifier: 05050474558359
• UDI-Public: (01)05050474558359(17)231006
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: company representative,foreig
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/06/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000245
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 06/10/2021; 08/19/2021
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 07/09/2021; 08/20/2021
• 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