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 Codes	Corneal Edema (1791); Inflammation (1932)
Date of Event	11/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explant date: not applicable, as lens was not explanted.Initial reporter telephone number: (b)(6).Device evaluation: the product testing could not be performed as the product was not returned (the lens remains implanted).The reported complaint cannot be confirmed.Manufacturing record evaluation: based on the manufacturing record review and historical review there is no indication of a product malfunction or quality deficiency.No nonconformity report, escalation, documentation is required.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.An attempt has been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that patient underwent left eye cataract extraction with intraocular lens implantation on (b)(6) 2020, the operation went well.After operation, tobramycin dexamethasone eye ointment was used to cover the eyes.The patient was reexamined on (b)(6) 2020: vision of left eye was 0.8, conjunctiva was not hyperemia and detumescence, cornea was detumescence (+), anterior chamber was often deep, tyn (+), pupil was often large, intraocular lens was in positive position, and other structures were (-).Intraocular pressure: 16.7mmhg, the patient was given mydriasis immediately.Tobramycin dexamethasone eye drops frequently and other symptomatic treatment.The patient was reexamined on (b)(6) 2020: 0.8 in left eye, no congestion and swelling of conjunctiva, corneal endothelial fold (+), anterior chamber often, tyn (-), pupil is often large, intraocular lens is in positive position, and other structures are the same as before.At present, the patient's condition is improved.No further information available.

• 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: 11325520
• Report Number: 2648035-2021-07233
• Device Sequence Number: 17178690
• Product Code: HQL
• UDI-Device Identifier: 05050474557994
• UDI-Public: (01)05050474557994(17)221030
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2021

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: 10/30/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000065
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 02/12/2021
• 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: 56 YR