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	Corneal Edema (1791); Eye Injury (1845)
Date of Event	06/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of birth: information unknown/ not provided.Patient weight and ethnicity: information unknown/ not provided.Initial reporter telephone number: (b)(6).(b)(4).Device evaluation: product testing could not be performed since the product was not returned for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that two (2) additional complaints ¿ dc-preloaded did not locked¿ and lathe lines¿ have been received for this production order.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.
Event or Problem Description
It was reported that the lens was prepared according to instructions, no problems with advancement and implantation.The intraocular lens (iol) was implanted, then it was found that the iol was missing a haptic.The lens was explanted at a later date and another johnson and johnson lens of the same model was implanted.It was reported that the incision was enlarged during the explant procedure.Patient presented with cornea guttata the day of the explant, pre-operative visual acuity (va) was 0.5.Doctor believed there were fewer endothelial cells remaining after the explant.However, edema was observed on the first day with 0.1 va.Va readings on the second day of the iol exchange was 0.5.The surgeon has not recommended any additional intervention as patient has not reached visual stability.Follow-up revealed that the patient's operative eye was the right side and that the missing haptic was not found in the eye.Emmetropia was the target; however, planned result was not achieved.No additional information was provided.
Additional Manufacturer Narrative
Additional info: section d9 - device available for evaluation? yes.Section d9 - returned to manufacturer? yes.Section d9 - date returned to manufacturer: 26th july 2021.Device evaluation: the lens was returned inside a small container.The lens was outside of the preloaded system.The lens had a detached haptic.Viscoelastic residues were observed on lens surfaces.The pcb00 device was observed in advance position.Complaint issue reported ¿haptic detached¿ was verified.However, the condition in which the sample returned is consistent with a product that was handled and prepared for a surgical process.Production deficiency can not be determined.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.

• 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: 12215594
• Report Number: 2648035-2021-08147
• Device Sequence Number: 4062555
• Product Code: HQL
• UDI-Device Identifier: 05050474558243
• UDI-Public: (01)05050474558243(17)221113
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2021

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: 11/13/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 09/21/2021
• 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
• Patient Age: 80 YR